Job Title: Manager Quality Engineering (m/f/d)
We are seeking a Manager Quality Engineering (m/f/d) for our customer, a leading pharmaceutical company in Biel/Bienne.
Key Responsibilities:
1. Lead and guide a team of Quality Engineers to ensure the delivery of high-quality products.
2. Develop and implement Switzerland-specific validation strategies, including equipment qualifications, process validations, room commissioning, and routine validations linked to VMP.
3. Collaborate with site production, operations, maintenance, and quality teams to drive quality excellence.
4. Act as the quality representative during product or process investigations and external/internal audits.
5. Design and execute validations, technical studies, test method validations, and other studies/reports.
6. Support risk management processes and associated documentation applicable to STAAR Surgical AG.
7. Initiate and lead project teams on Corrective Action/Preventive Action (CAPA) projects.
8. Serve as a formal back-up for the Quality Manager.
Requirements:
1. Masters degree in Quality, mechanical, life sciences, or industrial engineering preferred.
2. Minimum five years' experience or advanced degree with three years of experience in leading quality engineering groups in the medical device or pharmaceutical industries.
3. Excellent English language skills, both spoken and written. Additional languages are an asset.
4. Proficient IT Skills (e.g. MS Office, eQMS).
5. Flexible and adaptable to change, able to work under pressure.
6. Responsible, team-oriented, and well-organized personality.