Product Quality Engineer - QC

For one of our clients, we are looking for a Product Quality Engineer - QC . The ideal candidate possesses a strong quality mindset, enjoys collaborating across various interfaces in a large organization, and has a natural affinity for precise documentation. Technical expertise and knowledge of laboratory diagnostics, along with the ability to manage stressful situations, are essential.

General Information:

• Start Date: ASAP
• Planned Employment Duration: One-year contract
• Extension: Highly probable
• Location: Rotkreuz
• Workload: 100%
• Remote/Home Office: Partially possible, onsite presence required
• Travel: Minor travel (1x per semester)
• Department: Production Engineering
• Work Hours: Standard
• GMP Environment Access: Yes

Responsibilities:

• Ensure and verify product quality for assigned products throughout the assembly and testing chain.
• Approve assigned products and escalate if defective items are identified.
• Manage and review deviations (e.g., Q-reports).
• Coordinate Q-reports to address supplier errors identified in production.
• Analyze quality data and regularly conduct Product Quality Meetings.
• Create, update, review, and provide training on standard documents, instructions, and reports, as well as review validation and qualification documents.
• Handle specific CAPA and ECR tasks.
• Act as system owner for test stations, responsible for calibration/maintenance of equipment, and create relevant documentation.
• Implement continuous improvement (KVP) measures.

Must-Haves:

• EITHER a university degree in medical technology, mechanical engineering, or a similar technical field OR a technical qualification (EFZ) in areas like toolmaking or polymechanics, with practical experience in quality assurance or in diagnostic/molecular biology labs, preferred.
• Initial professional experience / At least 1 year of experience in a mass production company
• Initial professional experience / At least 1 year of experience in quality assurance, quality engineering, or test planning (GxP environment)
• Practical experience in a regulated GxP environment, ideally in medical technology or IVD (ISO 13485, FDA 21 CFR 820, IVDR/MDR)
• Excellent communication skills in German and English (spoken and written) required

Nice-to-Haves:

• Practical experience with Six Sigma methodology
• Experience handling complaints and deviation reports
• Advanced IT skills (SAP; Tableau; statistical analysis)
• Strong stakeholder and expectation management skills within interdisciplinary teams
• Experience in a highly regulated production environment
• Knowledge in molecular biology, especially sequencing

If you meet the qualifications and are interested in this opportunity, please apply.