A global medical device manufacturer are looking for their new experienced Quality System Manager to take control of their department and show their exceptional leadership skills.
In this role, you will be responsible for:
* Ensuring the Quality Management System (QMS) aligns with QSR, ISO 13485, MDD/MDR, MDSAP, and other relevant country-specific regulatory requirements as specified in QMS-CORP-000886.
* Providing leadership and technical expertise in the implementation of Quality Management solutions within a regulated environment.
* Developing, supporting, and implementing a strategic vision for the digital transformation of the QMS to enhance safety, quality, reliability, and resilience across the supply chain.
* Managing the change management, training, documentation control, and quality system teams.
* Ensuring compliance with key QMS processes, including Document, Training and Change Management, CAPA, NCR, and Complaint Handling, as well as Internal and External Audit Management.
* Collaborating with the Corporate Quality Organization to maintain compliance with OneQMS and fostering effective relationships with other Quality Partners.
We are seeking candidates with:
* A Bachelor's degree or equivalent qualification.
* In-depth knowledge and understanding of FDA, MDSAP, ISO 13485, and other relevant regulatory requirements.
* Ideally 8 years of industry experience in a Quality Systems or similar role within a Class III or Class II Medical Device or Pharmaceutical Company, with proven management experience.
* Certification in auditing, with experience in internal/external and regulatory audits.
* Fluency in French and English (written and spoken).
* Excellent technical writing and communication skills.
* Green Belt or Six Sigma certification is an asset.
* Profound digital literacy and proven experience using digital QMS tools.
* A dynamic and engaging individual with strong cross-functional teamwork capabilities, able to work independently with minimal supervision.