Quality Engineer

vor 1 Tag


Lausanne, Schweiz i-Pharm GxP Vollzeit

Quality Engineer

We’re seeking an experienced Quality Engineer to lead initiatives in compliance, CAPA resolution, and quality systems remediation for medical devices and combination products. This is a fantastic opportunity for professionals passionate about driving quality improvements in a dynamic and regulated manufacturing environment.

Key Qualifications:

  1. 7-10 years of experience in Quality Assurance Engineering.
  2. Fluency in French (written and spoken).
  3. Expertise in CAPA management, ISO 13485, and technical file remediation.
  4. Proven experience in medical device/combination product manufacturing.
  5. Familiarity with auditing, inspection readiness, and compliance standards.

Key Responsibilities:

  1. Collaborate with engineering and quality teams to resolve CAPAs and close gaps in compliance.
  2. Address ISO 13485 compliance issues in quality documentation and technical files.
  3. Assist in remediation of quality systems and ensure alignment with regulatory requirements.
  4. Prepare manufacturing processes and documentation for audits and inspections.

If you feel you would be a right fit for this opportunity, or know someone who is looking for a new role and could be a great fit, do apply.

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