I am on the search for a Quality Engineer for a key client of mine in Switzerland. The ideal candidate must meet the below requirements and expertise.
Key Requirements:
- Proven experience with injection moulding and medical devices.
- Strong understanding of quality assurance processes and standards in the medical device industry.
- Hands on mentality and keen to work on-site
- Fluent German and English
Responsibilities:
- Quality Assurance: Ensure all products meet the required quality standards.
- Project Involvement: Participate in projects from inception through the entire product life cycle.
- Functional Knowledge: Understand the function and application of all parts produced.
- Test Planning: Define and implement test plans to ensure product quality.
- Production Flow: Develop and maintain PFMEA, identify critical characteristics, and create control plans.
- Validation/Qualification: Develop and execute validation and qualification plans.
- Quality Monitoring: Use statistical process control (SPC) to monitor quality and define inspection severity based on current quality levels.
- Decision Making: Make decisions on special releases or disposal of products.
- Audits: Supervise customer audits and conduct supplier audits to ensure compliance.
- Complaint Handling: Manage and resolve complaints related to products.
Skills and Competencies:
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Detail-oriented with a focus on continuous improvement.
Education and Experience:
- Bachelor's degree in Engineering or a related field.
- Minimum 5 years of experience in quality engineering, preferably in the medical device industry.
