Mindray
Quality Officer, Europe - based in Creteil, France
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Responsable Qualité, Europe - Based in Creteil
Location:
Créteil, France | Île de France, France
Area:
Europe
Compensation:
Highly Competitive Salary + Excellent Benefits + Career Enhancement
Reporting to:
Global QMS Manager
Position Overview:
Become part of one of the fastest-growing med-tech companies globally.
Due to Mindray’s sustained growth and market expansion, we are seeking a highly experienced expert to contribute to service excellence within a high-performing and rapidly evolving organization.
With a solid background in Quality Management within the medical device capital equipment sector, the ideal candidate demonstrates proven experience in organizational and developing Quality Systems.
Beyond technical expertise, this role requires a strong commitment to quality, compliance, and continuous improvement. The successful candidate will act as a key contributor to service reliability, operational efficiency, and customer satisfaction across France. They will operate with a high level of autonomy, rigor, and accountability, ensuring adherence to internal procedures, regulatory requirements, and quality standards.
A solution-oriented mindset, combined with strong communication, influencing, and stakeholder management skills, will be essential to drive service performance and support strategic initiatives. The ability to work in a dynamic, fast-paced environment while maintaining a structured and quality-driven approach is critical.
In return, you will work with advanced technologies in a context of sustained double-digit growth, within a collaborative and innovation-driven environment, supported by experienced leadership and a strong commitment to quality and operational excellence.
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 the 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 the main point of contact during regulatory interactions.
- Directly engaging with regulatory authorities to address complex regulatory inquiries and communications.
- Providing strategic advice and support to headquarters for decision-making.
- Acting 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.
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What We Are Looking For:
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- English oral and written is the working language.
- Bachelor's degree or equivalent in quality, law, medicine, pharmacy, engineering, or another relevant scientific discipline.
- At least 8 years of work experience and 5 years in managing Quality Management Systems, preferably in the 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 the 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 are going to be critical in the success of our delivery through your phenomenal influencing and negotiation skills at a senior level, brought to Mindray, you get a ‘seat at the table’ and play a truly instrumental role, for this you will be well rewarded with a strong work/life balance, competitive salary, excellent benefits, a highly inclusive and diverse environment, and opportunities for future career development in many areas.
Mindray Europe, as part of the global Mindray business, offers a wide selection of bespoke benefits dependent on your location, along with a competitive compensation package and a commitment to a long-term working relationship. With industry-leading training and development available to you, you are sure to have a highly rewarding and mutually beneficial career with Mindray, in a culture that values honesty and fun!
Our goal is to continuously improve and sustain an inclusive culture in which diversity provides deeper customer insights and creates a competitive advantage in the markets we serve. By attracting, developing, and engaging the best team of diverse, empowered associates, we help build success for ourselves and our customers.
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As English is our business language - please submit your CV and application in English.
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