Quality Engineer (m/f/d)
Location: Switzerland
Contract: [Full-time]
Start date: ASAP
About the Role
We are seeking a motivated and detail-oriented
Quality Engineer
to join our team. The successful candidate will play a key role in ensuring that customer quality requirements are met across all project phases, from planning to production and final release. This role requires strong technical knowledge, analytical thinking, and excellent communication skills to collaborate effectively with internal teams and customers.
Main Responsibilities
* Support requirement management within assigned projects
* Serve as the interface to customers to align on quality requirements
* Translate and cascade customer requirements into product, component, and service specifications
* Contribute to risk management (project risk assessment, design/process FMEAs)
* Develop quality planning documents (validation, control, and inspection plans)
* Conduct statistical analysis of process data
* Support OQ/PQ and MSA activities
* Manage internal release of final product (PPAP / FAI)
* Support change management for products and processes
* Negotiate and maintain customer quality agreements
* Prepare and support customer audits
Authority
* Approve or reject internal production processes (OQ/PQ)
* Block or release components and products
* Exercise veto rights at milestones when customer or internal quality requirements are not met
Qualifications
* Stern Med-Tech experience
* Technical education (FH/TS) or equivalent background
* Further education as a Quality Engineer
* Proficiency in quality methodologies: FMEA, validation planning, process capability studies, MSA, and 8D
* Strong technical understanding of manufacturing processes and metrology
* Solid knowledge of ISO 9001
* Fluent in
English (business level)
and
German
* Excellent communication and active listening skills, fostering a culture of openness and collaboration
Why Join Us
* Opportunity to work on cutting-edge projects in a dynamic environment
* Collaborative, quality-driven team culture
* Competitive compensation and long-term growth potential