Quality Engineer
vor 1 Tag
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:
- 7-10 years of experience in Quality Assurance Engineering.
- Fluency in French (written and spoken).
- Expertise in CAPA management, ISO 13485, and technical file remediation.
- Proven experience in medical device/combination product manufacturing.
- Familiarity with auditing, inspection readiness, and compliance standards.
Key Responsibilities:
- Collaborate with engineering and quality teams to resolve CAPAs and close gaps in compliance.
- Address ISO 13485 compliance issues in quality documentation and technical files.
- Assist in remediation of quality systems and ensure alignment with regulatory requirements.
- 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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