compliance engineer jobs

Near galway
29Jobs Found

29 jobs found for compliance engineer jobs Near galway

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Quality Engineer

itContracting

Galway, Galway
2 days ago
Galway, Galway
2 days ago
Quality Engineer (contractor)
itContracting is the Recruitment arm of Evros Technology Group. Established in 1990, we have offices across Ireland, and we use the latest technologies to deliver innovative and robust solutions to truly revolutionise the way businesses work. Our client base spans across Public/Private sector, with Indigenous or Global IT, Pharmaceutical and Med Tech companies, where highly regulated environments and industries feature heavily.
We are currently seeking a Quality Engineer to work as contractor at our client, a leading Med Tech company in Galway.
Job Purpose:
To execute Quality support activities under limited supervision and in accordance with all applicable local laws/regulations and Corporate procedures and guidelines.
Key Responsibilities:
  • Review DHR and Sterilization documents
  • Perform operational quality support
  • Provide technical support on organization’s quality processes within QMS
  • Support closure of CAPA/NC
  • Support in external and internal audit
  • Coordinate with external manufacturer
  • Work with cross functional teams and internal teams to create deliverables
  • Meet with project core team to review requirements and deliverables
  • Interpret new/ upcoming quality/ regulatory requirements and provide guidance
  • Performs other duties assigned as needed

Qualifications & Education:
  • Bachelor’s degree in an Engineering or Scientific related discipline

Experience & Skills:
  • Good experience in Medical Device Quality for Line Quality Operations
  • Knowledge of Medical procedures and corresponding Medical Equipment
  • Knowledge on Quality Management and its tools & techniques
  • Knowledge about FDA, ISO 13485 and compliance regulation
  • Knowledge on Medical Device Regulatory Standards, MDD and MDR
  • Knowledge on NC, CAPA, Audit processes
  • Knowledge in Statistic, Risk Management and Design control
  • Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills

Location:
Galway. Working Onsite at client location in Galway – all applicants must have a valid work authorization for Ireland and must be willing to relocate to Ireland for duration of the project.
Type of contract:
Contractor (12 months, extendable)
Candidates must be eligible to work in Ireland or currently hold a Stamp 4 Visa to apply.
If you are interested in applying for this role, please do so via the relevant link. If you would like to discuss this role in confidence, please contact Paola De Ambrosis and Jack Cremin in Evros directly.
Evros / itContracting is an equal opportunity employer who seeks to recruit and appoint the best available person for a job regardless of marital / civil partnership status, sex (including pregnancy), age, religion, belief, race, nationality and ethnic or national origin, colour, sexual orientation or disability. Evros / itContracting apply all relevant Data Protection laws when processing your Personal Data.
If you choose to apply to this opportunity and share your CV or other personal information with Evros / itContracting, these details will be held by us in accordance with our privacy policy used by our recruitment team to contact you regarding this or other relevant opportunities at Evros / itContracting.
Ref: EVR3479
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Sterilisation Validation Engineer I

Sigmar

Galway City, Galway
Today
Galway City, Galway
Today

Sterilisation Validation Engineer I | 18Month Contract | Galway.

Our client, one of Galway’s leading Medical Device company are looking for a Sterilisation Validation Engineer to join their team on an 18-month contract.

You will be working within the Sterilisation Validation Department where you will be focusing on product quality and work alongside Sterility Assurance for New Product Development. 

Initially for this role you will be remote. 

You will be responsible for:

  • Supporting Sterility Assurance activities for new products and change controls at both design and manufacturing sites.
  • Partake in root cause investigations and continuous improvement in your daily activity and initiate appropriate corrective actions and follow through to implementation.
  • Support EU MDR project work for Sterilisation Validation team.
  • Help support cross functional teams in design protocols to make sure that new products/ product changes are evaluated/ tested to guarantee compliance to all regulatory standards.
  • Support projects in internal and external audits and with submission preparation while also addressing any questions around these submissions.
  • Perform calculations, technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements.
  • Deliver on projects assigned and works with other stakeholders to achieve desired results within defined timeframes.
  • Adhere to all relevant site wide procedures and practices for Safety & GMP.

Your experience:

  • Degree (Level 8) qualification in relevant technical discipline such as Science or Engineering.
  • 2 years’ experience with Sterilisation Validation or Biocompatibility is preferred.
  • Excellent understanding of GMP and documentation required.
  • Can work effectively and proactively as an individual or on cross functional teams

 

 

If you are interested in this role please apply with an updated CV to Rebecca O'Connor at

ROconnor@sigmar.ie

 

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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Packaging Engineer

HRM Recruit

Galway, Galway
16 days ago
Galway, Galway
16 days ago

Our client is a global medical device healthcare solutions company who are committed to improving lives through medical technologies, services, and solutions. They operate across 350 facilities in 150 countries, with an innovative portfolio of over 46,000 patents. They are currently looking for a Packaging Engineer.
The Role
This exciting contract role is to provide support to the MDR packaging manufacturing implementation project.
Key Responsibilities would include:
  • Implement any changes to the packaging line as a result of MDR.
  • Ensure any MDR manufacturing changes achieve operational excellence.
  • Ensure processes and procedures are in compliance with MDR regulations.
  • Responsible for the installation, calibration and preventative maintenance of any process equipment related to MDR.
  • Support any packaging test builds related to MDR changes to the product packaging.
  • Support cross site engagement for any MDR components development activities.
  • Undertake specific projects as designated in support of the MDR business unit objectives.

The Person
In order to be considered for this exciting daily rate Packaging Engineer role, specific requirements for the successful candidate would include:
  • Degree qualified in engineering, science, or a technical equivalent.
  • 2-5 years of relevant work experience within the medical device industry.


What's on offer:
  • Exciting long-term daily rate contract role within a leading global healthcare solutions company
  • Opportunity to work within a global leader giving you access to build your portfolio within the medical device industry.
  • Potential for a long-term opportunity within the organisation.

To discover more about this opportunity, apply now or contact Laura Gallagher at HRM on +353 91 782 113 for a confidential discussion.
S
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Senior Manufacturing Engineer

Sigmar

Galway, Galway
4 days ago
Galway, Galway
4 days ago

Senior Manufacturing Engineer

Here in Galway, I'm recruiting for an experienced Senior Manufacturing Engineer to join a small but expanding medical device company. This is a permanent job and you will join a team of 4 experienced Engineers within the Manufacturing Group. You will focus on manufacturing and process development activities while working closely with R&D.

Your Responsibilities:

  • As as a Senior Engineer, you will frequently interact with product stakeholders (e.g. external vendors, production, quality, etc.) to identify opportunities and develop appropriate strategies
  • Work with and lead internal cross-functional teams and contract manufacturers or design firms to ensure system design, architecture, and verification/validation meets design input.
  • Evaluate external technologies and strategically identify opportunities to implement them.
  • You will serve as a key communicator from the customer to the design team.
  • As the Technical Expert (subject matter expert), you will be responsible for contributing and solving complex projects/issues as they arise.
  • Project Management: Create, drive, communicate & execute project plans, tasks and deliverables.
  • Develops processes, materials and solutions through in house and out of house development paths.
  • Use structured problem-solving techniques and statistical methods for data driven analysis and decisions
  • Build Quality into all aspects of work by maintaining compliance to all quality requirements
  • Provide technical guidance to other engineers & technicians.

Your Background:

  • Level 8 Engineering or Science Degree.
  • Experienced Engineer with 5 years in a medical device environment.
  • Experience with medical products such as large calibre delivery systems is an advantage
  • Product and process development skills in medical devices a must
  • Strong knowledge of materials and process capabilities for catheter based medical device implants
  • Strong working knowledge and ability to use statistical techniques, six sigma and DFSS methodology
  • Proficient in solid works, ACAD and FE
  • Ability to work within a team; fully motivated to achieve and demonstrate best practices in line with company objectives.
  • Excellent verbal communication skills to enhance collaboration and written skills to prepare/execute/communicate plans and reports
  • Strategic Planner with successful scheduling & execution results

For more information, please contact Emma on 091 455 307.

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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Quality Engineer I/II

Sigmar

Galway, Galway
9 days ago
Galway, Galway
9 days ago

Quality Engineer I/II

Our client, a leader in manufacturing medical devices is currently seeking a Quality Engineer I/ II to join their growing team in Galway. This is a 12-month contract with a view of becoming permanent.

This is a fantastic opportunity for career prospects.

Job responsibilities:

  • Summarizes, analyses, draws conclusions and makes appropriate decisions from test results
  • Has responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product
  • Participates in Customer Complaints investigation for areas under their control
  • Knowledge on QSR and ISO/ MDD standards
  • Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints
  • Knowledgeable on Risk Management, BSEN 14971 requirements
  • May participate directly in a new product/ technology transfer to ensure compliance to all internal and regulatory requirements
  • Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality
  • Familiar with the internal auditing process

Job requirements:

  • NFQ Level 8 qualification in a STEM discipline
  • Minimum 3 years’ experience in a Quality Engineering capacity

If you would like to discuss this position, reach out to Louise Whitty on 021 2359140 /

lwhitty@sigmar.ie

REF 98888

 

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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Project Quality Engineer II

Sigmar

Galway, Galway
10 days ago
Galway, Galway
10 days ago

This job offers excellent opportunities for career growth & professional development in a rich, diverse culture. 

What You Will Do:

  • Analyse data from test result / process related findings to draw conclusions & makes appropriate decisions
  • Make decisions related to product quality, including the disposition of non-conforming product
  • Complete investigations into Customer Complaints & create strategies for prevention & improvement
  • Liaise with EHS with regard to new equipment, processes, chemicals for environmental impact and create solutions to eliminate or lessen such impacts
  • Complete analysis of operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes
  • Participate in new product/technology transfers, ensuring compliance to all  regulatory requirements
  • Apply Lean Six Sigma principles to investigate and solve problems and improve quality
  • Mentoring / Coaching of junior team members

What You Will Need:

  • NFQ Level 8 Degree STEM discipline
  • Minimum of 3-4 years’ experience in Quality Engineering

What You Will Receive:

  • Excellent Salary & Comprehensive Benefit Package
  • Fast Tracked Career Progression
  • Collaboration with global teams

To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie  

 

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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.

B
B

Quality Engineer

BRIGHTWATER SELECTION (CORK) LIMITED

Galway, Galway
2 days ago
Galway, Galway
€45k - €55k Per Year
2 days ago
€45k - €55k Per Year

This is a fantastic opportunity for a Quality Engineer who is currently seeking a quick start to a new role. Two separate roles are available.

On offer is a 12 month contract with an attractive daily rate with start dates available in mid-March and early April.

Working at a client's medical device manufacturing facility you'll be responsible for either Line Support or Quality Documentation and QMS.

Line Support role:

  • Review DHR and Sterilization documents
  • Perform operational quality support
  • Provide technical support on organization’s quality processes within QMS
  • Support closure of CAPA / NC
  • Support in external and internal audit
  • Coordinate with external manufacturer

Documentation/QMS role:

  • Support Quality Documentation
  • Support Change Management activities
  • Provide technical support on organization’s quality processes within QMS

About You:

  • Degree Qualified in Science or Engineering
  • 2 - 5 years of experience in a Medical Device Quality role
  • Knowledge on Quality Management and its tools & techniques is required
  • Knowledge about FDA, ISO 13485 and compliance regulation
  • Knowledge on NC, CAPA, Audit processes
  • Knowledge in Statistic, Risk Management and Design control
  • Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills
  • All Candidates must hold an EU Passport or Stamp 4

For more on the role call Nigel on 087 3618142 or send your CV for consideration.

S
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Quality Engineer II (Line Support)

Sigmar

Galway, Galway
10 days ago
Galway, Galway
10 days ago

This job offers excellent opportunities for career growth & professional development in a rich, diverse culture. 

What You Will Do:

  • Analyse data from test result / process related findings to draw conclusions & makes appropriate decisions
  • Make decisions related to product quality, including the disposition of non-conforming product
  • Complete investigations into Customer Complaints & create strategies for prevention & improvement
  • Liaise with EHS with regard to new equipment, processes, chemicals for environmental impact and create solutions to eliminate or lessen such impacts
  • Complete analysis of operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes
  • Participate in new product/technology transfers, ensuring compliance to all  regulatory requirements
  • Apply Lean Six Sigma principles to investigate and solve problems and improve quality
  • Mentoring / Coaching of junior team members

What You Will Need:

  • NFQ Level 8 Degree STEM discipline
  • Minimum of 3-4 years’ experience in Quality Engineering

What You Will Receive:

  • Excellent Salary & Comprehensive Benefit Package
  • Fast Tracked Career Progression
  • Collaboration with global teams

To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie  

 

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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.

S
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Design Assurance Engineer

Sigmar

Galway, Galway
25 days ago
Galway, Galway
25 days ago

What You will Do:

  • Ensure, maintain and enhance compliance within Design Assurance Laboratory
  • Lead Laboratory team in Quality decisions and behaviors
  • Adhere to all Design Assurance Laboratory and relevant site wide procedures and practices for Safety & GMP
  • Support review and release of test data
  • Develop & maintain a deep understanding of processes and products to support process improvements
  • Lead Audit preparation and follow up
  • Drive laboratory investigations, identifying root causes using robust root cause analysis tools and sound engineering principles
  • Initiate corrective and preventative actions and follow through to implementation
  • Support Change Control - Initiate Change Orders to support documentation updates, draft changes & justifications and drive to completion in a timely manner
  • Devise and lead continuous improvements activities within the Design Assurance department

What You will Need:

  • Minimum of Degree level 8 in Engineering / Science or related discipline with a minimum of 2 years of relevant experience.
  • Experience working in the medical device or other regulated industry.

What You will Receive:

Excellent salary & benefits package, career advancement opportunities

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.

T
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Quality Engineer

TCS

Galway, County Galway
1 day ago
Galway, County Galway
1 day ago
Job Purpose and primary objectives:  | To execute Quality support activities
Key responsibilities (please specify if the position is an individual one or part of a team):  | Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, the duties and responsibilities for this position are:•Review DHR and Sterilization documents•Perform operational quality support•Provide technical support on organization’s quality processes within QMS•Support closure of CAPA / NC•Support in external and internal audit•Coordinate with external manufacturer •Work with cross functional teams and internal teams to create deliverables• Meet with project core team to review requirements and deliverables•Interpret new/ upcoming quality/ regulatory requirements and provide guidance•Performs other duties assigned as needed

Key Skills/Knowledge: | • Knowledge of Medical procedures and corresponding Medical Equipment• Knowledge on Quality Management and its tools & techniques• Knowledge about FDA, ISO 13485 and compliance regulation• Knowledge on Medical Device Regulatory Standards, MDD and MDR• Knowledge on NC, CAPA, Audit processes• Knowledge in Statistic, Risk Management and Design control• Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills

Experience required: | Good experience in Medical Device Quality for Line quality operations

Job Type

Contractor, Full Time

Posted

2 days ago

Description

Quality Engineer (contractor)

 

itContracting is the Recruitment arm of Evros Technology Group. Established in 1990, we have offices across Ireland, and we use the latest technologies to deliver innovative and robust solutions to truly revolutionise the way businesses work. Our client base spans across Public/Private sector, with Indigenous or Global IT, Pharmaceutical and Med Tech companies, where highly regulated environments and industries feature heavily.

 

We are currently seeking a Quality Engineer to work as contractor at our client, a leading Med Tech company in Galway.

 

Job Purpose:

To execute Quality support activities under limited supervision and in accordance with all applicable local laws/regulations and Corporate procedures and guidelines.

 

Key Responsibilities:

 

  • Review DHR and Sterilization documents
  • Perform operational quality support
  • Provide technical support on organization’s quality processes within QMS
  • Support closure of CAPA/NC
  • Support in external and internal audit
  • Coordinate with external manufacturer
  • Work with cross functional teams and internal teams to create deliverables
  • Meet with project core team to review requirements and deliverables
  • Interpret new/ upcoming quality/ regulatory requirements and provide guidance
  • Performs other duties assigned as needed
 

Qualifications & Education:

  • Bachelor’s degree in an Engineering or Scientific related discipline
 

Experience & Skills:

  • Good experience in Medical Device Quality for Line Quality Operations
  • Knowledge of Medical procedures and corresponding Medical Equipment
  • Knowledge on Quality Management and its tools & techniques
  • Knowledge about FDA, ISO 13485 and compliance regulation
  • Knowledge on Medical Device Regulatory Standards, MDD and MDR
  • Knowledge on NC, CAPA, Audit processes
  • Knowledge in Statistic, Risk Management and Design control
  • Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills
 

Location:

Galway. Working Onsite at client location in Galway – all applicants must have a valid work authorization for Ireland and must be willing to relocate to Ireland for duration of the project.

 

Type of contract:

Contractor (12 months, extendable)

 

Candidates must be eligible to work in Ireland or currently hold a Stamp 4 Visa to apply.

 

If you are interested in applying for this role, please do so via the relevant link. If you would like to discuss this role in confidence, please contact Paola De Ambrosis and Jack Cremin in Evros directly.

 

Evros / itContracting is an equal opportunity employer who seeks to recruit and appoint the best available person for a job regardless of marital / civil partnership status, sex (including pregnancy), age, religion, belief, race, nationality and ethnic or national origin, colour, sexual orientation or disability. Evros / itContracting apply all relevant Data Protection laws when processing your Personal Data.

 

If you choose to apply to this opportunity and share your CV or other personal information with Evros / itContracting, these details will be held by us in accordance with our privacy policy used by our recruitment team to contact you regarding this or other relevant opportunities at Evros / itContracting.

 

Ref: EVR3479