Manufacturing Remediation Specialist
7 days ago
As a seasoned quality or manufacturing engineer, you have the opportunity to make a significant impact in our remediation program.
Job OverviewThis position requires expertise in process validation and CAPA implementation to drive site-wide improvements following an FDA inspection.
Main Responsibilities:- Collaborate with process owners to identify and rectify issues.
- Support process validation (IQ/OQ/PQ) and documentation updates.
- Drive closure of non-conformances and implement compliant solutions.
- Provide technical writing for quality and manufacturing documents.
- Cross-functional collaboration to ensure regulatory compliance.
- Engineering or Quality degree with 5-10 years' experience in med-tech.
- Background in remediation, process validation, CAPA, NCRs.
- Strong technical writing and documentation skills.
- Knowledge of 21 CFR Part 820 and ISO 13485.
The ideal candidate will possess excellent problem-solving skills, be able to develop compliant solutions, and work effectively across Quality, Manufacturing, and Regulatory teams.
Benefits include professional growth opportunities and a dynamic work environment.
To succeed in this role, candidates should be proactive, detail-oriented, and comfortable working in a fast-paced team environment.
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