Manager Quality Engineering (m/f/d) - Medical Device or Pharmaceutical
We are seeking a Manager Quality Engineering (m/f/d) to lead a team of Quality Engineers for our customer, a prominent pharmaceutical company in Biel/Bienne.
Key Responsibilities:
1. Lead and guide a team of Quality Engineers to ensure the highest standards of quality in medical device or pharmaceutical development.
2. Plan and drive Switzerland-specific validations, including equipment qualifications, process validations, room commissioning, and routine validations linked to VMP.
3. Support site production, operations, maintenance, and quality teams to maintain a seamless quality control process.
4. Serve as the quality representative during product or process investigations and external/internal audits.
5. Prepare and execute validations, technical studies, test method validations, and other studies/reports to ensure compliance with regulations.
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 to identify and address potential quality issues.
8. Act as a formal backup for the Quality Manager to ensure continuity and efficiency in quality management.
Requirements:
1. Master's 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 skills, both spoken and written. All other languages are an asset.
4. Proficient IT skills, including MS Office and eQMS.
5. Very flexible and adaptable to change, with the ability to work under pressure.
6. Responsible, team-oriented, and well-organized personality.
About Us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. We specialize in placing highly qualified candidates in IT, Life Science & Engineering fields. Our staff leasing and payroll services are free of charge for candidates and come with no additional fees.