Product Quality Engineer - QC
Randstad (Switzerland) Ltd.
Publication date:
26 October 2024Workload:
100%- Place of work:Rotkreuz
job details
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.
Luciana Sardo
- +41 58 201 55 55
- Basel Professionals IT & Life Sciences