Are you ready to take the lead in driving quality and compliance at one of the world’s leading medical technology companies? Join Stryker’s France Distribution Center as a Lead RAQA Specialist and help ensure we deliver life-changing medical devices with the highest standards of quality and regulatory excellence.

Key Responsibilities:

As a Lead RAQA Specialist, you will play a central role in ensuring regulatory compliance and quality. Your core responsibilities will include:

• Implementing and maintaining the Quality Management System (QMS) in accordance with ISO 9001 standards, Stryker global guidelines, and internal procedures.

• Driving continuous improvement by managing non-conformances, corrective and preventive actions (CAPAs), and contributing to cross-functional quality initiatives.

• Participating in the risk management process to identify and mitigate quality-related risks throughout the product lifecycle.

• Leading the qualification and evaluation of suppliers and distributors, in line with the audit schedule and corporate requirements.

• Planning and conducting internal audits and distributor audits, ensuring compliance and driving accountability.

• Supporting external certification audits (e.g., ISO, notified bodies) and ensuring audit readiness at all times.

• Ensuring document control and integrity of Quality Assurance documentation across the site.

• Providing targeted QA support for key Stryker France processes, including fiches navette and sterilization activities.

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Qualifications & Requirements:

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To thrive in this role, we are looking for candidates who bring both technical excellence and leadership capability:

• Bachelor’s or Master’s degree in Quality Assurance, Life Sciences, or a related field.

• 5+ years of experience in Quality Assurance or Regulatory Affairs within the medical device or pharmaceutical industry, ideally with direct experience in distribution center.

• Strong knowledge of ISO 9001 and experience implementing or maintaining Quality Management Systems.

• Familiarity with ISO 13485 is a plus.

• Proven experience in internal and supplier auditing (Lead Auditor certification is a plus).

• Solid understanding of risk management methodologies and quality tools.

• Strong organizational and communication skills, with the ability to collaborate across teams and influence stakeholders.

• Fluent in English and French, both written and verbal.