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.
TASKS
· 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.
REQUIREMENTS AND SKILLS
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