Posted: 14 September
Offer description
Manufacturing Engineer Role Overview
We are seeking a highly skilled Manufacturing Engineer to support our site-wide remediation program following an FDA 483.
* The successful candidate will collaborate with process owners to identify and rectify manufacturing process gaps, ensuring seamless operations and compliance.
* Validating manufacturing processes and updating quality systems to meet regulatory requirements.
* Documenting remediation efforts and ensuring audit-readiness through meticulous record-keeping.
* A minimum of 5-10 years' experience in the med-tech industry.
* A strong background in remediation, process validation, and regulatory compliance.
* Exceptional technical writing and documentation skills.
* Familiarity with 21 CFR Part 820 and ISO 13485 standards.
* The opportunity to work on high-profile remediation projects.
* Professional growth and development opportunities.
