Manufacturing Engineer Opportunity
A quality-focused manufacturing engineer is needed to support site-wide remediation and collaborate with process owners on compliance gaps.
Remediation Quality Engineer Role
This position involves manufacturing process validation, quality system updates, and documentation remediation. You will work closely with process owners on the floor to capture and remediate issues, support process validation and documentation updates, drive closure of corrective actions and implement compliant solutions, and provide technical writing for quality and manufacturing documents.
Key Responsibilities
* Collaborate with process owners to identify and address compliance gaps.
* Support process validation (IQ/OQ/PQ) and documentation updates.
* Drive closure of corrective actions and implement compliant solutions.
* Provide technical writing for quality and manufacturing documents.
* Ensure cross-functional collaboration for regulatory compliance.
Requirements
1. Engineering or Quality degree with 5-10 years' experience in the med-tech industry.
2. Background in remediation, process validation, and corrective actions.
3. Strong technical writing and documentation skills.
4. Familiarity with relevant regulations such as 21 CFR Part 820 and ISO 13485.