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