Quality Assurance Engineer

OBJECTIVE AND MAIN TASK OF THE FUNCTION

• Lead and drive Non‑Conformance investigations for components, finished goods, and product returns.
• Perform impact assessments, root cause analyses, and implement effective CAPAs.
• Coordinate cross‑functional teams to ensure timely resolution of quality issues.
• Drive continuous improvement initiatives based on NC trends and quality metrics.
• Support internal and external audits and maintain compliance with the Quality Management System (QMS).
• Contribute to quality reporting, and other QA projects as required.

• Lead and drive Non‑Conformance investigations related to component failures, finished goods failures, product returns, and other quality events.
• Perform comprehensive impact assessments, root cause investigations (e.g., 5 Why, Fishbone), and define, implement, and verify the effectiveness of corrective and preventive actions (CAPA).
• Coordinate cross‑functional investigation teams to ensure timely closure of quality events and compliance with internal procedures and regulatory requirements.
• Monitor and report NC metrics and trends, identifying opportunities for continuous improvement and systemic corrective actions.
• Lead and execute cross‑functional quality improvement projects to reduce recurring non‑conformances and improve product and process quality.
• Support the planning, execution, and response to internal Quality Management System (QMS) audits.
• Act as Subject Matter Expert (SME) and/or provide backroom support during external audits and regulatory inspections.
• Support continuous improvement of supplier qualification, supplier management, and incoming material inspection processes.
• Support supplier quality activities, including supplier qualification, performance monitoring, Supplier Corrective Requests (SCRs), supplier investigations, and supplier audits.
• Prepare, review, and maintain quality documentation, investigation reports, and monthly/quarterly quality trend analyses.
• Participate in and moderate Quality Assurance and Corrective Action review meetings.
• Collaborate closely with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and other departments to resolve quality issues and ensure product compliance.
• Perform other quality‑related duties and projects as assigned.

• Education:
  
  Bachelor’s degree in Engineering or Life Sciences
• Special Knowledge:
  Strong English skills, both written and spoken
• French and/or German, both written and spoken
• Good IT knowledge in MS office
• Personality:
  Excellent organization and communication skills
• Flexible and adaptable to change with ability to work under pressure
• Responsible, operate with integrity and teamwork
• Learning attitude and logical approach
• Professional
  
  Experience:
  
  At least 3 years of experience in Quality Assurance within Medical Device and/or Pharmaceutical fields is required