Senior Quality Engineer (Full‑time)

About the role

Join the newly established manufacturing site in Nidau as a Quality Engineer, supporting production, operations, maintenance, calibration and quality teams. You will lead equipment qualifications, validations and change assessments while representing quality in investigations and audits.

Key responsibilities

• Prepare, execute, review and lead equipment qualifications, validations, technical studies and test method validations.
• Initiate and lead change and impact assessments, managing equipment lifecycle requirements.
• Serve as the quality representative during product or process investigations and internal/external audits.

Required profile

• Bachelor’s degree in Quality, Mechanical, Life Sciences or Industrial Engineering.
• Minimum five years of experience in quality engineering within the medical device or pharmaceutical industry (or advanced degree with three years of experience).
• Excellent spoken and written English; additional languages are a plus.
• Flexible, adaptable, able to work under pressure and well‑organized.

Required skills

• Proficient with MS Office and electronic Quality Management Systems (eQMS).
• Knowledge of Kneat software is a plus.
• Knowledge of the Kaye Validator System is a plus.

What we offer

• 40‑hour work week with modern working spaces.
• Minimum 25 days of vacation and monthly health‑insurance contribution.
• Modern cafeteria, free parking and excellent public‑transport connections.
• Regular social events and training & development plans.