Post Market Surveillance Pms And Product Quality Review Pqr Engineer m H/F - Nemera

With sales of €700m and 3,300 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has built very long lasting, strong relationships with the leading global pharmaceutical companies globally by providing high quality development, industrialization and manufacturing services. Nemera develops and manufactures its own IP product platforms but also offers also fully custom developments and contract manufacturing.

Nemera's manufacturing sites are located in the US, France, Germany, Brazil and Poland. The headquarters and Innovation Center for early device design and development are located in France (Lyon).
We have big ambitions at Nemera! We are growing our franchises and strengthening our capabilities.

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

- 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 you're:

· 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 you'll be successful here!

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