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.
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