Post Market Surveillance (PMS) and Product Quality Review (PQR) Engineer MFX

At Nemera we are passionate about developing innovative drug delivery solutions that truly make a difference in patients lives. To support our continued growth we are currently looking for passionate people ready to make a difference in the following open position: Post market surveillance (PMS) and Product Quality Review (PQR) engineer F/M/X based in Lyon (7e).

The PMS and PQR Engineer will ensure the effective execution of PostMarket Surveillance (PMS) and Product Quality Review (PQR) activities for products under Nemeras industrial property. This includes assessing product compliance collaborating closely with development teams quality and production departments and interacting with customers.

This position reports to the Quality Manager.

Description of significant activities :

1. PMS & PQR Execution
   1. Collect and analyse data required for PQRs including complaints CAPAs deviations events and change controls in collaboration with Business Units Franchise teams and production sites.
   2. Maintain update and apply PMS procedures in alignment with Nemera internal standards EU MDR 2017/745 and FDA requirements.
   3. Perform PostMarket Surveillance of Nemera products.
   4. Plan track and report PMS activities.
   5. Plan PostMarket Clinical Follow-up (PMCF) activities when applicable.
   6. Contribute to quality regulatory and compliance intelligence monitoring.
2. Compliance & Documentation
   1. Ensure product compliance with applicable regulations and internal quality system documentation.
   2. Identify plan and support activities related to PQR PMS PSUR and PMCF.
   3. Prepare review and/or approve PMS PSUR PMCF and associated documentation for regulatory submissions and customer communication.
   4. Support internal and external audits and contribute to the definition of corrective and preventive actions.
3. Cross-Functional Collaboration
   1. Collaborate with Nemera sites Business Units and production locations to ensure activities are completed on time.
   2. Support continuous improvement initiatives for internal PMS/PQR-related processes.
   3. Act as a quality engineer supporting various Business Unit franchises.
   4. Participate in product risk analysis and quality improvement actions.

Qualifications :

• Experience in PostMarket Surveillance and Product Quality Review.
• Good knowledge of EU MDR 2017/745 ISO 13485 cGMP and legal manufacturer responsibilities for medical devices or pharmaceutical products.
• Fluent English (written and spoken).
• Strong analytical mindset and continuousimprovement orientation.
• Ability to synthesise complex information with rigor and attention to detail.
• Collaborative mindset and effective communication skills.
• Ability to take decisions within assigned responsibilities.
• Proactive autonomous and capable of managing initiatives.
• Ability to lead crossfunctional topics without hierarchical authority.

If youre:

Passionate about growing a business

Enjoy working as a team

Proud to make products that improve patients lives

And go the extra mile to deliver on your commitments

Then youll be successful here!

Youll help us achieve our corporate growth goals by bringing these skills to Nemera and have fun in the meantime !

Additional Information :

Our Recruitment Process

We believe in a transparent and straightforward recruitment process to ensure a great fit for both you and our team.
Heres what you can expect:
- CV Review: Upon receiving your CV our Talent Acquisition Team will review it to assess your qualifications for the role.
- Initial Screening: If your profile matches our requirements youll be invited for an initial screening call with a member of our Talent Acquisition Team.
- Interview with Hiring Manager: After the initial screening youll have an interview with the Hiring Manager to discuss your experience skills and fit for the role in more detail.
- Interview with N2: Following the Hiring Manager interview youll meet with the next level of management (N2) for further evaluation.
- HR Manager Interview: The final step involves an interview with our HR Manager to discuss company culture benefits and other HR-related topics.
- Offer: If all goes well youll receive an offer to join our team!

We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group if you want to discover more about Nemera please look at our website

Know someone at Nemera We have a Referral Program so be sure to have them submit you as a referral prior to applying for this position!

Chez Nemera nous valorisons la diversité et linclusion et nous nous engageons à créer un environnement de travail où tous les employés sont traités avec dignité et respect.
Nous sommes fiers dêtre un employeur offrant légalité des chances et nous encourageons les candidatures de toutes les origines genres orientations sexuelles âges et capacités.

Remote Work :

No

Employment Type :

Full-time