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. #J-18808-Ljbffr