Quality Engineer II
On-siteGrenchen, Solothurn, Switzerland or Bettlach, Solothurn, Switzerland
Grenchen, Solothurn, Switzerland or Bettlach, Solothurn, SwitzerlandOn-siteFull TimeEnterprise
Full TimeEnterprise
Job Summary
Lead validation strategies for new product introductions, technology implementations, and process improvements to ensure compliance and operational excellence. Plan, execute, and review validation activities including Process Validation (IQ, OQ, PQ), Computer System Validation (CSV), and Test Method Validations (TMV). Ensure adherence to GxP, GAMP, and ISO 13485 standards while maintaining thorough documentation for audits. Provide technical expertise on manufacturing equipment and processes to support design transfer and successful new product launches.
Required Qualifications
- Strong knowledge of GxP, GAMP, ISO 13485, and validation best practices
- Experience with Process Validation (IQ/OQ/PQ) and CSV activities
- Technical understanding of manufacturing processes and equipment
- Experience in medical device, pharmaceutical, or other regulated industries
- Knowledge of GxP, GAMP and ISO 13485 regulations and best practices are required
- Strong technical understanding of manufacturing equipment and processes is essential
Desired Qualifications
- Knowledge of new product introduction (NPI), design transfer, and equipment lifecycle management is highly desirable
- Experience in new product launches, equipment lifecycle management and design transfer is a plus
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