Work Flexibility: Hybrid

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.

Qualifications & Requirements:

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.

Travel Percentage: 10%