Quality Officer, Europe - based in Creteil, France

Quality Officer, Europe – Based in Creteil

Location: Créteil, France | Île de France, France

Area: Europe

Salary: highly competitive; benefits: excellent; career enhancement.

Reporting to Global QMS Manager.

Position Summary

The Quality Officer is responsible for ensuring that Mindray France’s Quality Management System (QMS) remains compliant with local regulations (e.g., MDR, IVDR), international standards (e.g., ISO 9001, ISO 14001), and corporate quality requirements. The role is also accountable for ensuring Post‑Market Surveillance (PMS) compliance across the entire EU region. In addition, the Quality Officer serves as a key liaison between the local entity and Mindray’s headquarters in China, facilitating effective communication, alignment of quality practices, and consistency in post‑market surveillance activities.

Your Responsibilities

• Overall responsibility for the establishment, maintenance and continuous improvement of Mindray France Quality Management System (QMS), ensuring compliance with applicable regulations (EU MDR/IVDR) and ISO standards (e.g. ISO 13485).
• Leading process owners in defining, implementing and improving QMS procedures, ensuring regulatory compliance while supporting operational efficiency and customer satisfaction.
• Ensuring effective implementation of risk management processes in accordance with ISO 14971, including integration into QMS and post‑market activities.
• Establishing, implementing and maintaining an effective CAPA system, ensuring root cause analysis, timely corrective/preventive actions and verification of effectiveness.
• Monitoring and assessing new regulatory requirements (local and EU) and ensuring timely integration into the QMS, while informing relevant stakeholders.
• Managing Management Review activities, including planning, preparation of inputs, facilitation, and follow‑up of actions.
• Planning and conducting internal audits and supplier audits, ensuring proper qualification, performance monitoring, and compliance of external providers.
• Supporting and coordinating external audits and inspections (e.g. notified bodies, ANSM), ensuring readiness and maintenance of certifications and licenses.
• Managing change control processes to ensure all changes are assessed, documented, approved and compliant with regulatory requirements.
• Driving continuous improvement of the QMS, ensuring alignment between HQ requirements and local implementation.
• Ensuring effective post‑market surveillance activities in EU region, including customer complaints handling, vigilance reporting (incidents, serious incidents, FSCA), in collaboration with HQ and local teams.
• Managing quality‑related training programs to ensure personnel competence and awareness.
• Ensuring proper document and record control in compliance with QMS requirements.
• Monitoring quality performance through KPIs and ensuring data‑driven decision making and responsible for CAPA improvements.
• Collecting and maintaining objective evidence to demonstrate QMS effectiveness and compliance.
• Collaborating cross‑functionally (Service, Sales, Customer Support) to ensure quality and regulatory compliance across operations.
• Establishing and maintaining strong relationships with regulatory authorities (e.g. ANSM, BfArM and other EU authorities) and acting as main point of contact during regulatory interactions.
• Directly engage with regulatory authorities to address complex regulatory inquiries and communications.
• Provide strategic advice and support to headquarters for decision‑making.
• Act as the local post‑market regulatory expert, guiding EU subsidiaries implementation of the regulatory requirement.
• Any other task or activity from time to time in relation to Quality.
• Responsible for providing quality support to QMS activities and post‑market issue handling for other European countries (outside France), in coordination with local stakeholders and HQ.

What We Are Looking In You

• English oral and written is the working language.
• Bachelor degree or equivalent in quality, law, medicine, pharmacy, engineering or another relevant scientific discipline.
• At least 8‑year work experience and 5‑year in manage Quality Management System, preferably in medical device industry is vital.
• Good global knowledge of quality.
• ISO9001 or ISO13485 and ISO14001 auditor certified or trained is preferred.
• A strong communicator with excellent written and oral communication skills.
• Skilled at building consensus and able to influence outcomes without relying on line management authority.
• Experience at working both independently and in a team‑oriented, collaborative environment.
• Able to conform to shifting priorities, demands and timelines.
• Willing to travel in EU and Mindray HQ.
• QualioPi knowledge is preferred.

What’s in it for you

This is an outstanding position for candidates that are really looking for a role with autonomy, accountability and responsibility. You will be critical to the success of our delivery through your persuasive influence and negotiation skills at a senior level. Mindray offers a strong work/life balance, competitive salary, excellent benefits, a highly inclusive and diverse environment, and opportunities for future career development. Mindray Europe offers a wide selection of tailored benefits, a competitive compensation package, and long‑term working relationship commitment. With industry‑leading training and development, you will have a highly rewarding career. Our goal is to continuously improve and sustain an inclusive culture in which diversity provides deeper customer insights and creates a competitive advantage.

As English is our business language – please submit your CV and application in English.