QM/Quality Engineer

Vor 7 Tagen

St Gallen, Sankt Gallen, Schweiz EPM Scientific Vollzeit

Direct message the job poster from EPM Scientific

Recruitment Consultant - Medical Device - QA/RA and R&D

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 in 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.
Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing

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