Job Overview:
We are seeking a seasoned Quality Assurance Specialist to support our remediation program. The ideal candidate will collaborate with manufacturing and quality teams to drive compliance improvements and process validation initiatives.
Main Responsibilities:
* Work closely with manufacturing process owners to identify and address compliance gaps.
* Support the development of quality system documentation and technical files to ensure audit readiness.
* Drive closure of nonconformities (NCRs) and corrective actions (CAPAs).
* Contribute to effective technical writing for quality procedures.
Required Qualifications & Experience:
* Bachelor's degree in Engineering or a related field.
* At least 25 years of experience in medical device manufacturing, quality, or remediation projects.
* Strong knowledge of process validation and CAPA/NCR management.
* Familiarity with quality standards such as ISO 13485.