A global leader in dental products and technologies, with over 100 years of life science innovation under their belt, is seeking a Senior Manager QA for its advanced facility just outside of Gothenburg.
You'll play a pivotal role in a dynamic environment, contributing to the company's longstanding commitment to oral health and the wider medical device sector.
As Senior QA Manager, you will:
- Oversee the quality management system, ensuring compliance with FDA, MDR/MDD, and other regulatory standards.
- Lead regulatory authority audits.
- Ensure validation and verification of products and processes.
- Maintain a validation system for new products and processes in accordance with current standards.
- Collaborate closely with Manufacturing, Engineering, and R&D teams.
- Promote continuous improvement in QA functions.
- Manage the QA team, aligning with the Quality Strategy and business objectives.
- Handle the QA department's budget and personnel management.
The ideal candidate should have:
- Extensive experience in Quality Assurance/Control in the medical device industry.
- Knowledge of US FDA 21 CFR Part 820 and ISO 13485:2016.
- Familiarity with EU Medical Device Regulation (EU) 2017/745.
- Experience in Notified Body Audits and FDA Inspections.
- Managerial experience, including personnel and budget oversight.
Candidates are encouraged to apply immediately for this crucial role. This position offers an exceptional opportunity to contribute significantly to a field that impacts lives across the globe. For more information or similar roles in the sector, please get in touch.