compliance engineer jobs

Near waterford
7Jobs Found

7 jobs found for compliance engineer jobs Near waterford

F
F

Quality Engineering Lead

FRS Recruitment

Waterford, Waterford
2 days ago
Waterford, Waterford
2 days ago

Position Summary:
The Quality Engineer Lead assists in development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses. Ensures that performance and product quality conform to established company, customer and regulatory requirements. Assists in the review, analysis and reporting on quality discrepancies related to assembly and process. May investigate problems and recommend disposition, modification and corrective action for recurring or non-recurring discrepancies. Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met.
Key Responsibilities
  • Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
  • Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA's & support the generation of DMF's where appropriate.
  • Individual with an experienced background in sterilisation, automation, equipment/software validation.
  • Individual with an experienced background in manufacturing within controlled environments.
  • Individual shall support the external & internally Quality Management System auditing function (auditor trained).
  • Individual shall have exposure & involvement in supporting the CAPA system.
  • Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
  • Support the implementation of Company Policies and GMP.
  • Support all company safety and quality programs and initiatives.
  • Ensure ongoing compliance with GMP in all practices, recording of events and processes.
  • Ensure compliance with all learnings from all GMP training events.
  • Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.


Requirements
  • Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline.
  • 5 years' experience in a Quality Engineering role in a regulated environment.
  • Fully competent in Quality Management Standards.
  • People Management experience

Skills/Attributes:

  • Excellent Leadership skills, ability to motivate team members within the organisation. (Energetic & enthusiastic individual).
  • Excellent organisation, communication, computer & presentation skills.
  • Excellent initiative, decision making and be able to work in a core team environment.
  • Solution driven with emphasis on performance and results.

Organization Linkages:
  • Reports to Site Quality Lead
  • Plant wide Teams and Managers.
  • Customers, Contractors, Vendors and Suppliers.
S
S

Manufacturing Engineer

Sigmar

Waterford, Waterford
21 days ago
Waterford, Waterford
21 days ago

Are you a Manufacturing Engineer with strong problem solving & validation skills? This could be the perfect role for you!

This company is a leader in medical devices spaces based in county Waterford!

Job responsibilities:

  • Designing manufacturing processes, procedures, and production layouts. 
  • Developing manufacturing processes and measurement systems.
  • Developing relevant work instructions and SOP’s and provides guidance to operations on training.
  • Providing guidance to operations regarding design concepts and specification requirements.
  • Ensuring processes and procedures are in compliance with regulations.
  • Delivering and managing projects within an agreed schedule.
  • Working with internal and external customers and partners to deliver on projects.
  • Utilizing LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement.
  • Writing and executing process and equipment validations (IQ/OQ/PQ).

 

Job Skills & Experience:

  • 3rd Level Engineering Degree with a good hands-on working knowledge of medical device assembly.
  • 4+ years of relevant experience in a highly regulated environment, 
  • Proven track record in the execution of protocols and validations to regulatory requirements.
  • Successful track record of project managing validation activities and cost reduction projects.
  • Technical knowledge of Automated Systems (Pneumatic, Electro-pneumatic, Robotic)
  • LEAN, Six Sigma experience
  • Monitoring of materials, equipment and process flows during validation and ramp-up related activities to ensure high levels of performance and OEE.
  • Process background (development, capability, optimization, validation) within a regulated industry.

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel@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.

P
P

CSV Engineer

Prochem Engineering

Waterford, Waterford
1 day ago
Waterford, Waterford
1 day ago

Role Purpose

               

  • Under limited supervision, participates as a team member in qualification/validation activities related to laboratory instrument/equipment systems including computer systems.
  • The position additionally provides lead duties by providing technical assistance and training.

 

Duties

 

  • Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
  • May supervise, coordinate, prioritize and lead the daily activities of a group of qualifiers/validators and schedule their workloads.
  • Designs qualification/validation plans and protocols; researches and writes documents in support of project directives for the qualification/validation of instrumentation/computer systems. Performs and may oversee the development of qualification/validation activities for instrumentation and supporting software.
  • Develops and oversees the creation of Standard Operating Procedures related to instrumentation including the administration of related supporting software.
  • Maintains appropriate documentation of records, report sheets and laboratory logbooks as required by Standard Operating Procedures (SOPs).
  • Provides scientific and technical leadership to junior staff members to ensure project deadlines and performance standards are met. Collaborates closely with Supervisor to set priorities and reach objectives.
  • Surveys literature to remain current with developments in analytical instrumentation qualification and computer systems validation.
  • Prepares and presents written reports on qualification/validation activities.
  • Provides formal and informal training to laboratory personnel on instrumentation usage.
  • Selects, justifies, and implements appropriate instrumentation, computer systems, and procedures to achieve product development support objectives.
  • Ensure compliance with all Company policies and procedures, including safety rules and regulation.
  • Performs related duties as assigned.

 

 

Qualifications and Knowledge

 

  • Bachelor’s Degree in Science or related scientific filed from an accredited college or university, and nine (9) years related pharmaceutical laboratory experience, or an equivalent combination of education and experience.
  • Responding to inquiries from management, employees and regulatory agencies.
  • Working with a high degree of independence and of conceiving and achieving technical goals with little or no technical supervision.
  • Training of junior staff.
  • Leading the activities of technical personnel; making decisions and satisfying the needs of a qualification/validation program.
  • Communicating clearly and concisely, both orally and in writing.
  • Operating scientific and personal computers.
  • Managing multiple projects, duties and assignments.
  • Coordinating and reviewing the work of assigned department personnel.
  • Technical Report Writing
  • Establishing and maintaining cooperative working relationships with others.
  • Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
  • Pertinent SOPs related to analytical instrumentation qualification and computer system development life cycle.
  • Data Integrity principals as they related to regulatory rules, regulation and guidelines.
  • FDA, CGMP, and SOP regulatory rules, regulation and guidelines.
  • Business, English usage, spelling, grammar and punctuation.
  • Business, scientific and personal computer hardware and software applications.
  • Supervision, leadership and training practices and methods.
  • Current Company policies, practices and procedures, including safety rules and regulation.
C
C

Validation Engineer

Crest Solutions

Waterford
16 days ago
Waterford
16 days ago

Crest Solutions have an open position for a Validation Engineer to join our team.


In the Validation Engineer role, you will be required to support capital projects/equipment qualification, new product introductions and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of equipment, systems and processes. The following activities will be included as part of your role:


Responsibilities


       Designing, executing and reporting on validation studies for equipment, systems and processes.

       Ensuring validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)

       Providing technical interpretation and guidance of current US FDA and EU validation requirements for solid dose manufacture, aseptic processing, lyophilisation, sterilisation and depyrogenation

       Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times

       Maintaining validation documentation through the validation lifecycle

       Participation in external regulatory inspections


Requirements & Qualifications

  • Relevant Engineering or Science qualification. Previous validation experience in sterile manufacturing, solid dose and devices would be highly advantageous for the role. 
  • 39 hour week with typical hours 8:00 to 16:30 (Mon-Thurs) and 8:00 to 15:30 (Fri) with occasional requirements to work outside these core hours and for business travel. The role reports to the Validation team leader.
  • You will have the opportunity to work in an energetic friendly team where team-work is essential. Due to the diverse of the site and the validation work, you will get exposure to many areas of the business with the chance to grow your career and develop your technical and professional skills. 

Why join Crest Solutions?


In Crest Solutions we understand that our people are our greatest asset. For this reason and many others, we take care of them. As part of the Crest Solutions team, you will be exposed to, and have the opportunity to work with, the latest cutting-edge technologies. The experience you gain in Crest Solutions will be multi-faceted.

This role also includes great personal benefits and professional growth opportunities. An example of what is offered to our team members is as follows:

        Competitive salary

        Full healthcare cover, leave benefits, life assurance, flexi-time and pension scheme

        A varied and exciting career with Crest Solutions with opportunities to work in a cutting-edge, innovative technological environment

        A structured approach to professional development opportunities with an educational assistance programme

I
I

Quality Engineer III

Integer

New Ross
30+ days ago
New Ross
30+ days ago
At Integer, our vision and values are embedded in everything we do!
If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!
JOB SUMMARY
The Senior Quality Engineer will primarily be responsible for developing and maintaining all quality systems and monitoring production process for compliance to implemented process controls. Under minimal direction, manages Quality projects that may cover multiple sites. Duties will involve coordination, and scheduling of program or project activities. Assignments are broad in scope with the opportunity for the use of independent judgment. Essential Quality engineering skills are required.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
Employees are expected to support the quality concepts inherent in the business philosophies of Integer, including a variety of job-related tasks which may not be specific to this position profile.
POSITION REQUIREMENTS
Interfaces directly and regularly with customers (internal and external) staff. Often is included in critical business discussions with customers to bring deep insight to a problem or opportunity and establish a high level of credibility for Integer through demonstrated program management knowledge and expertise.
Proactively manage the risk associated with projects so that Integer’s and the customer’s business objectives are achieved. Minimize the uncertainties associated with projects relative to scope changes, customer expectations, business issues and other intangibles to enable successful completion of projects.
Involve and coordinate the input of all key functional groups and contributors to the proposed work plan.
Follows and develops Quality and Regulatory requirements including Integer’s policies, procedures, and appropriate regulatory requirements and have the standard Quality engineering skill set as outlined below.
Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common Integer tools & templates were available.
As outlined above must have standard Quality engineering skills as outlined below:
1. Compliance with all Regulatory Standards, this includes:
Completion of internal audits to: ISO 13485 FDA QSR ISO 14000
b. Participation in Corporate auditing programs
c. Ensuring continued compliance with DMR
2. Develop and maintain a program ensuring only correctly validated equipment is used in production process. This will include:
Participation in validation protocol development Overseeing completion of validation or validation samples Supporting the engineering function to ensure compliance to related element of quality system
3. Liase with engineering departments on new product development projects to ensure;
All quality control requirements for non standard product are clearly understood All product samples for new product development qualification are inspected Relevant process controls are documented and transferred to production and suitably implemented with necessary training.
4. Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
Trend analysis of data from the controls
Potential improvements for review with engineering based on the trends
Areas for Improvement to senior management
Review and propose changes to sampling plans based on trend analysis and changes to the system
5. Maintenance of customer concerns handling system in a timely manner including
Returned product analysis Organisation, filing and reporting of customer concerns
Ensure the requirements of the Electronic Documentation Management system
are understood and implemented at all levels of the organization.
Accountable to monitor manufacturing activities, measure significant process characteristics and analyse variation in order to detect and reduce waste
Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements. Play a leadership role in encouraging the Company to achieve world class standards, above all by setting your own high professional standards as an example.
SKILLS AND KNOWLEDGE:
Ability to communicate and work with people inside and outside the department.
Excellent communicator: verbal, written and presentation skills.
Ability to train and lead assigned employees.
Ability to co-ordinate, plan and organise in a timely manner.
Knowledge of engineering theories and methods.
Rigorous attention to detail.
Ability to use Microsoft Office Suite (Excel, Project, Word, PowerPoint at a minimum) and ability to use / learn Oracle as the company ERP system (preferably Oracle)
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
+ Demonstrate leadership in project management
+ Engineering, Science or Project Management Degree preferably with Quality Engineering included
+ Qualified systems lead auditor
+ Program Management certification or number of years experience
Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at https://integer.net .
Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy and gender), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at
716-759-5739.
T
T

Facilities Engineer

Takeda Pharmaceutical

Ireland
1 day ago
Ireland
1 day ago

Job Description

  • Safe and efficient operation of site life systems, such as Fire Alarm, Gas Detection and Access Control.
  • Effective contractor management.
  • Continuous improvement initiatives to enhance the operations in Facility areas.
  • Responsibility for the operation and maintenance of all site Facility systems on site, including but not limited to; Access Control, Fire Alarm System, Pest Control, Security, Site Communications, Sprinklers, Grounds & Building Fabric Maintenance, Plant Uniforms & General soft services.
  • Ensure all regulatory compliance requirements are fulfilled.               
  • Ensure correct spares are specified and maintained at adequate levels to maintain operations.
  • Operate planned and unplanned maintenance systems as defined in Engineering Department procedures.  Implement procedures for new equipment as required.  
  • Develop and implement maintenance strategies and plans for all equipment in Facilities.
  • Manage Department performance against defined KPIs.
  • Control and monitor safe working practices of team members and contractors while on site.
  • Support the Technology Transfer initiatives for incoming new products. This requires good communication and close cooperation with key Technology Transfer personnel from other departments.
  • Implement training programs and maintain up to date training records for key contractors such as Security personnel.       
  • Instigate maintenance improvement projects to improve availability and efficiency.
  • Lead quality investigations relating to Facility systems.
  • Ensure compliance with the Quality Department Document Management System.
  • Participate in the control of Safety and Environmental programmes.  Adhere to safe working practices as set out in the Safety Statement and other company safety rules.
  • Participate fully in cross-functional training initiatives.
  • Provide regular reports on the activities of the Facility & Utility group
  • Assist with the formation and control of operational budgets.
  • Leadership of site programmes to manage certain High Risk activities.
  • Participate in site EHS activities and ensure that the Facility personnel comply with legislation and best practice.
  • Actively foster an ethos and culture of safety awareness, where safety is accepted as an integral part of the overall business.
  • Work with all GC personnel, contractors and visitors to ensure that all safety policies, procedures and regulations are fully adhered to across the site on an ongoing basis.
  • Ensure compliance with legislative requirements as applicable to engineering/ maintenance systems.
  • Ensure that team are well trained to safely and effectively carry out their roles. Develop training for relevant personnel with a particular focus on direct operational and technical support personnel.
  • Preparation and delivery of training material as required.
  • Ensure timely completion of all SOP training and assessment tasks.
  • Ensure that all training and assessment is accurately and promptly recorded for themselves and other relevant personnel in accordance with TILGC procedures.
  • Maintain and improve their professional knowledge base. Keep up to date with all current trends and relevant legislation.
  • Participate fully in any cross functional training initiatives.
  • Drive and promote the corporate values of Takeda-ism within the workplace.
  • Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Beacon Events are completed in a timely manner after an event.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
  • 3rd level Engineering, or equivalent, required.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
No More Results

Job Type

Full Time

Posted

2 days ago

Description


Position Summary:

The Quality Engineer Lead assists in development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses. Ensures that performance and product quality conform to established company, customer and regulatory requirements. Assists in the review, analysis and reporting on quality discrepancies related to assembly and process. May investigate problems and recommend disposition, modification and corrective action for recurring or non-recurring discrepancies. Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met.



Key Responsibilities
  • Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
  • Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA's & support the generation of DMF's where appropriate.
  • Individual with an experienced background in sterilisation, automation, equipment/software validation.
  • Individual with an experienced background in manufacturing within controlled environments.
  • Individual shall support the external & internally Quality Management System auditing function (auditor trained).
  • Individual shall have exposure & involvement in supporting the CAPA system.
  • Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
  • Support the implementation of Company Policies and GMP.
  • Support all company safety and quality programs and initiatives.
  • Ensure ongoing compliance with GMP in all practices, recording of events and processes.
  • Ensure compliance with all learnings from all GMP training events.
  • Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.





Requirements
  • Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline.
  • 5 years' experience in a Quality Engineering role in a regulated environment.
  • Fully competent in Quality Management Standards.
  • People Management experience


Skills/Attributes:

  • Excellent Leadership skills, ability to motivate team members within the organisation. (Energetic & enthusiastic individual).
  • Excellent organisation, communication, computer & presentation skills.
  • Excellent initiative, decision making and be able to work in a core team environment.
  • Solution driven with emphasis on performance and results.



Organization Linkages:
  • Reports to Site Quality Lead
  • Plant wide Teams and Managers.
  • Customers, Contractors, Vendors and Suppliers.