compliance engineer jobs

Near limerick, limerick
39Jobs Found

39 jobs found for compliance engineer jobs Near limerick, limerick

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Senior Quality Engineer

Webrecruit Ireland

Limerick, Limerick
30 days ago
Limerick, Limerick
30 days ago

Senior Quality Engineer

Limerick, Co. Limerick

 

The Company

 

Fleming Medical is a market-leading pharmacy supplies company based in Limerick which has grown internationally by design innovation in consumer healthcare products.

 

They are now seeking a Senior Quality Engineer to join their team in Limerick.

 

The Benefits

 

- Competitive salary

- VHI cover

- 20 days’ holiday

- Join a successful regulated medical device and healthcare distribution business

 

This is the ideal role for a quality-focused professional with an excellent grasp of quality assurance and regulatory standards to advance their career with a growing and highly successful organisation.

 

You will have the chance to play a pivotal role in building the company’s operational excellence across a diversified product portfolio.

 

So, if you want to support the delivery of pioneering products that are helping healthcare professionals across the globe to save lives, our client wants to hear from you.

 

The Role

 

As the Senior Quality Engineer, you will be tasked with driving compliance and continuous improvement of the site quality management system to the required quality and regulatory standards.

 

Driving compliance with activities such as new product introduction, supplier quality, change control, complaints, NC & CAPA, you will also seek to drive improvements to meet KPIs.

 

Managing and controlling document with the QMS, you will seek to improve QMS documents and systems, co-ordinate internal audits and identify and implement operational improvement initiatives.

 

Additionally, you will:

 

- Drive Quality requirements related to New Product Introduction

- Continuously assess the regulatory impact on new product releases or product updates

- Maintain appropriate product records to demonstrate compliance

- Develop appropriate trending analysis and sampling plan reviews

- Prepare for and participate in external regulatory inspections

 

About You

 

To be considered as a Senior Quality Engineer, you will need:

 

- Good knowledge of quality assurance and regulatory standards

- Good technical writing skills and experience

- Good computer skills including knowledge of Microsoft, ERP and QMS database systems

- Good communication and interpersonal skills with the ability to communicate clearly and concisely in both spoken and written form

- Attention to detail and accuracy to deal effectively with literature and data reviews

- To be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements

 

A third level qualification in a related discipline would be beneficial to your application, as would experience working in a similar quality assurance related role in the Medical Device Industry.

 

Other organisations may call this role Quality Engineer, Manufacturing Compliance Engineer, QA Engineer, Quality Assurance Engineer, QMS Engineer, or Compliance Engineer.

 

Webrecruit Ireland and Fleming Medical are equal opportunities employers, value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be.

 

To apply for the role of Senior Quality Engineer, please apply via the button shown. This vacancy is being advertised by Webrecruit Ireland Ltd. The services advertised by Webrecruit Ireland Ltd are those of an Employment Agency.

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Senior Embedded Engineer (C++) - R&D Medical Devices - Limerick

ITSearch

Limerick, Limerick
9 days ago
Limerick, Limerick
9 days ago

Senior Embedded Engineer (C++) - R&D Medical Devices - Limerick

 

My client based in Limerick is a world leading firm in the area of wearable technology and medical devices and has engaged IT Search to speak to candidates regarding this challenging senior role that will work within R&D to create complex medical devices.

 

The role is to join an existing global team headquartered here as a Senior team member, mentoring more junior staff but bringing significant expertise to the R&D team in the areas of designing, testing and implementing embedded processes at all levels of the architecture. Working within compliance and regulatory guidelines, this role will allow the Senior Engineer to produce cutting edge technological solutions to the medical community.

 

This will be a hybrid onsite/remote role so candidates will need to be based within a commuting distance.

 

Candidates should have:

  • 5 to 10 years of commercial development experience using C++ post graduation, ideally within a pharmaceutical or highly regulated environment
  • Ideally Firmware development experience
  • Linux (embedded) ARM and Cortex skills and architectural knowledge
  • Exceptional communications skills, able to work with multiple areas of the business and various locations and have a track record of strong documentation

 

To learn more about the role, client and process, please forward your CV stating required salary and availability and we can arrange a discussion.

 

Please note, we can only accept applications from candidates eligible to work in the EU

 

 

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Senior Quality Engineer - Design Assurance

Sigmar

Limerick, Limerick
7 days ago
Limerick, Limerick
7 days ago

Senior Quality Engineer – Design Assurance

American multinational company that specializes in medical technology that manufactures and sells medical devices in looking for a Senior Quality Engineer – Design Assurance to join their growing team in Limerick. This is a full-time, permanent position.

Job responsibilities:

  • Be responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction
  • Write project quality plans
  • Lead risk management activities within the project
  • Participate within project core Teams to test protocol definition based on applicable specification and relevant requirements
  • Review and approve related execution deviations
  • Assist / conduct Failure investigations and problem – solving sessions
  • Ensure process validation activities are completed appropriately and make the link with product design whenever needed

Job requirements:

  • Minimum level 8 degree in a related discipline and have proven experience in design assurance including design controls and risk management 9ISO 14971), reviewing and approving test protocols, SPC, experience working with Design History Files (ISO 13485)
  • Medical device sector experience

If you would like to apply to this role, please reach out to Louise Whitty on 021 2359140 /

lwhitty@sigmar.ie

REF6747DBLIM

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

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Document Controller

Adecco Retail

Shannon, Clare
4 days ago
Shannon, Clare
€23k - €30k Per Year
4 days ago
€23k - €30k Per Year

Essential Responsibilities:
*To review documentation pack with a technical review and pull documents requested / applicable to the order.
*Import applicable specs into Documentation depot and maintain revisions to standard.
*Liaise and resolve any complex punch list queries from third party inspectors.
*Maintain process documentation and processes for product
compliance to ensure ISO standards are maintained
*Drive a continuous improvement methodology, identify and drive defective
documentation with correct and preventive actions
*Maintain familiarity with Products in order to provide accurate documentation
*Challenge and support as appropriate where best practice is identified
and/or implemented.
*Capture all required information for execution of project Documentation - Templates, language, Index's, Hard / soft copys etc.
*Manage translation requirements and schedule to meet order T.A.T.
*Continuously liaise with the customer and the Project Engineer, managing submittals, returns and amendments through system as per agreed schedule.
*Source and prepare material certification for all certified product as per traceability provided.
*Support Project manager with order documentation queries and supply updates /documents as required.
*Attend KOM /R3 / weekly project meetings as needs be.
Qualifications/Requirements:
*Experience within Documentation teams previously is advantageous.
*Previous Experience with SAP ERP System or similar alternative systems.
*Knowledge in API certified Subsea equipment.
*Experience in a manufacturing / Project environment or a fast paced industrial role
*Ability to interface and communicate effectively with all levels of employees, management and diverse audiences.
*Attention to details, excellent analytical, critical thinking, problem solving and good personal organisation skills
*Proficient in software applications MS Word, Abobe Reader/ Nitro Pro, Excel is Important.
Desired Characteristics:
*Excellent communication skills, interpersonal, oral and written
*Effective at managing multiple priorities under a tight deadline
*High attention to detail and accuracy
*Accountable, takes responsibility for decisions, actions and results
*Resourceful, seeks simple solutions to complex problems
*Teamwork, builds trust by respecting the ideas and contributions of everyone
*Passionate, demonstrates enthusiasm for lean processes
Adecco Ireland is acting as an Employment Business in relation to this vacancy.
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Automation Engineer

LSC

Tipperary, Tipperary
2 days ago
Tipperary, Tipperary
2 days ago

LSC have a great contract opportunity for a PAT & Labs Engineer to join a top 10 Pharmaceutical company based in Tipperary.
If you have specific experience in the design, implementation and qualification of Process Analytical technologies is a requirement - SIPAT is preferable, Multivariate analysis, NIR and other technologies and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
o Partner with local project teams to deliver Automation and IT aspects of Process Analytical Technologies and Laboratory systems for capital projects
o Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with company standards.
o The expectation is that this role will grow to be the PAT SME for MMDIT project teams. Successful candidate should Coach, mentor and provide technical training to colleagues.
o Understand and educate local project teams on automation standards as they relate to technology selection, system configuration, SDLC, validation, hardware, software environments and business processes.
o Work closely with the QA-IT function to ensure compliance with company Quality standards.
o Provide input to the development of project schedules and document trackers.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
o BS in Engineering, Computer Science, or other technical degree.
o 3 or more years of experience in project automation/IT support in a Life Sciences environment with direct technical and SDLC experience.
o Familiarity with real time release using PAT technologies would be advantageous
o Experience with Process Automation systems and/or Laboratory systems in a Life sciences environment is desirable.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply
Apply via this advert or contact Paul O'Driscoll at LSC on 021-4777329 if you have anymore questions about this PAT & Labs Engineer opportunity!
ABOUT LSC - CONTRACTING WITH A DIFFERENCE
LSC
work exclusively in the Life Science sector and have designed a Consultant Success Programme to help make the contracting process as easy and rewarding as possible for all our consultants....visit www.lscconnect.com to find out more
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Senior Quality compliance Engineer - Design Assurance

BD

Limerick
30+ days ago
Limerick
30+ days ago

Job Description Summary

Job Description

The Design assurance QE is involved in new product development and product maintenance through the application of Quality engineering skills.  Must be able to handle multiple projects and tasks, from product inception through product launch and maintenance utilizing a high level of written and oral communication skills. Plays an active role in the processes to ensure products meet quality standards consistent with both Corporate and division policies, while meeting all design controls, risk management, change control requirements and other applicable regulatory requirements. Represents the Quality Function on Project Teams for both new product development and existing products.

As a Senior Quality Engineer you will :

  • Be Design Assurance Quality Engineer on project core teams (PM, R&D, RA, Clinical, Marketing, Systems Engineering, Software Engineering) for design change projects and develop close relationship with other quality functions (plant quality engineering, Supplier quality assurance…) as needed for the project .

  • Be responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction. Adaptively apply working knowledge of quality engineering concepts within the product lifecycle.

  • Write project quality plans

  • Lead risk management activities within the project.

  • Participate within project core Teams to test protocol definition based on applicable specification and relevant requirements. Review and approve test protocol and reports. Review and approve related execution deviations.

  • Assist / conduct Failure investigations and problem-solving sessions

  • Review and challenge statistical rationale, plan and data analysis in the frame of test protocol / reports.

  • Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.

  • Ensure process validation activities are completed appropriately and make the link with product design whenever needed.

  • Conduct quality functional reviews and DHF compliance reviews.

  • Ensure compliance across projects for design control, risk management and change control processes. Support Quality culture within R&D organization while providing training on applicable requirements / standards.

The successful candidate will have a minimum level 8 degree in related discipline and have proven expertise in design assurance including design controls and risk management (ISO 14971), reviewing and approving test protocols, SPC, experience working with Design History Files (ISO 13485) and have experience working in the medical device sector. Additional experience with Software Quality (ISO 62304), Capital equipment validation and reliability testing is an advantage.

If you’re a team player who is passionate about Engineering and ‘advancing the world of health’ and we’ve just described your career aspirations, then please click on the APPLY button where you will be directed to our website to apply directly.

Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: https://emea.jobs.bd.com/

Primary Work Location

IRL Limerick - Castletroy

Additional Locations

Work Shift

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Senior Supplier Quality Engineer

Edwards Lifesciences

Shannon
8 days ago
Shannon
8 days ago
Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.
Key Responsibilities:
• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards
• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
• Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
• Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• Other incidental duties assigned by Leadership
Education and Experience:
Bachelor's Degree or Equivalent in in Engineering or Scientific field , 4 years years experience of industry experience or industry/education Required or
Master's Degree or equivalent in in Engineering or Scientific field , 3 years years experience of industry experience or industry/education Required or
Ph.D. or equivalent in in Engineering or Scientific field industry experience or industry/education
Additional Skills:
• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required (if applicable)
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of applicable FDA regulations for medical device industry
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
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Quality Engineer J5802

Independent Solutions

Limerick, Limerick
7 days ago
Limerick, Limerick
7 days ago
⦁ JobTitle:  
Quality Engineer J5802

⦁ About Company:
Our client based in Limerick is seeking a Quality Engineer to join its expanding team.

⦁ Duration of Job: 12 months

⦁ Summary Objective:
The Quality Engineer will be responsible for providing leadership and supporting to root cause investigation activities, and ensures good Quality.
Engineering practices are used in investigations. The Quality Engineer will drive continuous improvement through data-driven approaches and monitoring of quality systems.


⦁ Job Duties:
• Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
• Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
• Addresses and corrects product and process complaints.
• Reports on contract manufacturer performance metrics and ensures management reviews.
• Oversees audits of all quality system categories to assess compliance to process excellence standards.
• Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management.
• Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
• Responsible for supporting the activities of Operations/Engineering/information management in building quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness.
• Leads and executes upgrades to Quality System.
• Support QA programs in assuring compliance to the pertinent regulation.
• Identify and lead cost and technical improvements under the departments’ continuous improvement program.
• Provide key inputs and leadership into transformational process developments.
• Project Management - provide timely and accurate reporting on project activities.
• New Product Introductions & Product Transfers
• Lead or actively participate in cross-functional teams to ensure New Product Introduction/Research and Development projects are completed in a timely and efficient manner.
• Actively interfacing with cross-functional team members, always practicing good teamwork in support of day-to-day operating requirements.
• Demonstrate strong leadership and a clear identifiable work ethos within the team.
• Develop and maintain a Credo & Behavioural Standards based culture within the group.
• Ensure effective closure on Quality System documents (Audit Actions, NCR’s, CAPA’s, Maps, etc).
• Ensure all process developments, NPI etc are managed in accordance with the Quality management system.
• Implementation of safety/environmental requirements on purchase of all new equipment.
• Work with team leader to develop and implement strategic engineering.

⦁ Goals & Objectives.
• Support the implementation of all engineering and plant strategic initiatives.
• All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.
• Maintains and develops risk management lifecycle.
• Ensuring continuous improvement and understanding of measurement systems used on-site, driving down variance in test methodology.
• Develops site knowledge on manufacturing process knowledge, and monitors inputs and outputs to the processes, and implements and drives corrective actions.
• Sustains and advocates Credo based standards in all aspects of work.
• Supervise others if required.


Note: Responsibilities and accountabilities will vary for all positions and the scope of individual roles may not be limited to the contents of this position description. QUMAS procedures will define responsibilities from time to time and each manager is responsible for complying with these processes, which supplant any responsibility outlined within. As such, adherence to company procedures is also a responsibility of any roles encompassed within this Job Description.

Requirements

⦁ Education and Experience

• Degree Qualified with 3-5 years relevant experience in Medical Devices/Pharmaceutical Industry
• Ability to work on own initiative
• Flexible work ethic
• Attention to detail
• Excellent working knowledge of process excellence / QE tools such as pFMEA, SE, statistical analysis, SPC
• Excellent IT skill (eg.: experience in minitab, excel reports4).
• CAPA and RCI experience
• Risk management experience
• Automated process controls experience
• Good presentation skills
• Supervision of others


Benefits

Benefits

Benefits of working with Independent Solutions

  • Benefit from Independent Solutions ethical principles!
  • We look after our team, we know the business, we have been working in the sector >20 years.  We are not a recruitment agency
  • While placed on client sites you will be an integral part of our team, gaining support and  access to the knowledge and experience of our cross functional LifeScience team
  • We offer attractive rates - competitive margins compared to our competitors.
  • Payment on time and in full
  • We continue to partner and grow our client base and thereby ensure that we have continuous supply of High-Value Projects
  • We work for you !


⦁ Education and Experience • Degree Qualified with 3-5 years of relevant experience in Medical Devices/Pharmaceutical Industry • Ability to work on own initiative • Flexible work ethic • Attention to detail • Excellent working knowledge of process excellence / QE tools such as pFMEA, SE, statistical analysis, SPC • Excellent IT skill (eg.: experience in minitab, excel reports4). • CAPA and RCI experience • Risk management experience • Automated process controls experience • Good presentation skills • Supervision of others
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Supplier Quality Engineer

Edwards Lifesciences

Shannon
30 days ago
Shannon
30 days ago
The Company: Edwards Lifesciences is driven by a passion to help patients. The company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
Key Responsibilities:
• Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Develop moderately complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
• Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Develop, update, and maintain technical content of risk management files
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Other incidental duties assigned by Leadership
Education and Experience:
Bachelor's Degree in in Engineering or Scientific field , minimum of 2 years years experience Required or
Master's Degree or equivalent internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education Required
Additional Skills:
• Good computer skills in usage of MS Office Suite
• Ability to read and interpret drawings
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
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Electronic Engineer - Documentation- 12 Month FTC

BD

Limerick
30+ days ago
Limerick
30+ days ago

Job Description Summary

Are you ready to make a difference in this world? Do you want to be part of a team that develops ground-breaking medical and biotechnology services and devices? One person can make a singular difference in saving and improving lives. At BD, we are looking for amazing, passionate and dedicated people like you. BD, a company standing on 120 years of innovation in medical technology, is currently recruiting talented individuals to join our new Research and Development (R&D) Centre of Excellence in Limerick. BD’s purpose is to advance the world of health. As part of our team, you will be on the forefront of creating and developing specialized devices, software solutions and systems to help others. Our new Centre in Limerick provides you with cutting edge technology and a creative environment to be inspired to tap into your inner genius. You are the one who can make the difference. Join us and be a crucial part of advancing the world of health!

Job Description

BD is looking for a highly talented Electronic/Electrical Engineer, or a Quality or Regulatory Engineer with a strong Electronic/Electrical Engineering background, who will be responsible for creating, reviewing and updating documentation on existing products in line with the requirements of the EU MDR, along with defining and executing testing to generate evidence to demonstrate compliance. As part of an expanding team you will have excellent opportunities to broaden your knowledge and potentially develop your career within a Global business.

As an Electronic Engineer you will:

  • Define and execute testing on electronic assemblies and printed circuit board assemblies to demonstrate electro-mechanical medical device product compliance.

  • Work with cross functional teams such as mechanical, software, systems, quality and regulatory engineering to contribute to project schedules and project budgets in the coordination of overall product development.

  • Evaluate and update existing documentation (including product requirements, design specifications, test protocols and reports) to ensure compliance with the EU MDR.

  • Participate in technical design reviews to ensure electrical design integrity and safety are achieved.

The successful candidate will have a minimum level 8 degree in Engineering and at least 4 years industry experience. Electronics knowledge is required, along with experience of working in a regulated environment (Medical, Automotive, or Military/Aerospace).

If you’re a team player who is passionate about Engineering and ‘advancing the world of health’ and we’ve just described your career aspirations, then please click on the APPLY button where you will be directed to our website to apply directly.

Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: http://bd.tal3nt.community/

Primary Work Location

IRL Limerick - Castletroy

Additional Locations

Work Shift

Job Type

Full Time

Posted

30 days ago

Description

Senior Quality Engineer

Limerick, Co. Limerick

 

The Company

 

Fleming Medical is a market-leading pharmacy supplies company based in Limerick which has grown internationally by design innovation in consumer healthcare products.

 

They are now seeking a Senior Quality Engineer to join their team in Limerick.

 

The Benefits

 

- Competitive salary

- VHI cover

- 20 days’ holiday

- Join a successful regulated medical device and healthcare distribution business

 

This is the ideal role for a quality-focused professional with an excellent grasp of quality assurance and regulatory standards to advance their career with a growing and highly successful organisation.

 

You will have the chance to play a pivotal role in building the company’s operational excellence across a diversified product portfolio.

 

So, if you want to support the delivery of pioneering products that are helping healthcare professionals across the globe to save lives, our client wants to hear from you.

 

The Role

 

As the Senior Quality Engineer, you will be tasked with driving compliance and continuous improvement of the site quality management system to the required quality and regulatory standards.

 

Driving compliance with activities such as new product introduction, supplier quality, change control, complaints, NC & CAPA, you will also seek to drive improvements to meet KPIs.

 

Managing and controlling document with the QMS, you will seek to improve QMS documents and systems, co-ordinate internal audits and identify and implement operational improvement initiatives.

 

Additionally, you will:

 

- Drive Quality requirements related to New Product Introduction

- Continuously assess the regulatory impact on new product releases or product updates

- Maintain appropriate product records to demonstrate compliance

- Develop appropriate trending analysis and sampling plan reviews

- Prepare for and participate in external regulatory inspections

 

About You

 

To be considered as a Senior Quality Engineer, you will need:

 

- Good knowledge of quality assurance and regulatory standards

- Good technical writing skills and experience

- Good computer skills including knowledge of Microsoft, ERP and QMS database systems

- Good communication and interpersonal skills with the ability to communicate clearly and concisely in both spoken and written form

- Attention to detail and accuracy to deal effectively with literature and data reviews

- To be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements

 

A third level qualification in a related discipline would be beneficial to your application, as would experience working in a similar quality assurance related role in the Medical Device Industry.

 

Other organisations may call this role Quality Engineer, Manufacturing Compliance Engineer, QA Engineer, Quality Assurance Engineer, QMS Engineer, or Compliance Engineer.

 

Webrecruit Ireland and Fleming Medical are equal opportunities employers, value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be.

 

To apply for the role of Senior Quality Engineer, please apply via the button shown. This vacancy is being advertised by Webrecruit Ireland Ltd. The services advertised by Webrecruit Ireland Ltd are those of an Employment Agency.