Post Market Surveillance (PMS) and Product Quality Review (PQR) Engineer M/ at Nemera

Lyon, Auvergne-Rhône-Alpes, France -

Full Time

Start Date

Immediate

Expiry Date

14 Jun, 26

Salary

0.0

Posted On

16 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Post Market Surveillance, Product Quality Review, EU MDR 2017/745, ISO 13485, cGMP, Data Analysis, CAPA Management, Deviation Management, Change Control, Regulatory Submissions, Auditing, Continuous Improvement, Risk Analysis, Cross-Functional Collaboration, Analytical Mindset, Communication

Industry

Medical Equipment Manufacturing

Description

Company Description 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. Job Description 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 Post‑Market 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 Post‑Market Surveillance of Nemera products. Plan, track, and report PMS activities. Plan Post‑Market 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. Qualifications Experience in Post‑Market 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 continuous‑improvement 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 cross‑functional 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 ! 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. Here's 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, you'll be invited for an initial screening call with a member of our Talent Acquisition Team. - Interview with Hiring Manager: After the initial screening, you'll have an interview with the Hiring Manager to discuss your experience, skills, and fit for the role in more detail. - Interview with N+2: Following the Hiring Manager interview, you'll meet with the next level of management (N+2) 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, you'll 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 www.nemera.net 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 l'inclusion et nous nous engageons à créer un environnement de travail où tous les employés sont traités avec dignité et respect. Nous sommes fiers d'être un employeur offrant l'égalité des chances et nous encourageons les candidatures de toutes les origines, genres, orientations sexuelles, âges, et capacités. Employment Classification: Cadre Nemera Department: Global Quality & Regulatory Contract Type: CDI Legal entity: Nemera La Verpillière

Responsibilities

The engineer will execute Post-Market Surveillance (PMS) and Product Quality Review (PQR) activities for Nemera's intellectual property products, which involves collecting and analyzing relevant data in collaboration with various departments. This role also requires maintaining PMS procedures aligned with EU MDR and FDA requirements, planning PMCF activities, and contributing to compliance monitoring.