Quality Remediation Professional
4 days ago
The ideal candidate will play a pivotal role in supporting a site-wide remediation program following an FDA inspection. As a Compliance Specialist, you will collaborate closely with cross-functional teams to drive compliance improvements and process validation initiatives.
About the Role:
Purpose: To support a critical site-wide remediation program following an FDA inspection
Key Responsibilities:
- Partner with manufacturing process owners to identify and remediate compliance gaps.
- Support manufacturing process validation activities (IQ/OQ/PQ).
- Update quality system documentation and technical files to ensure audit readiness.
- Drive closure of CAPAs and NCRs with effective corrective actions.
- Provide clear and concise technical writing for quality and manufacturing procedures.
- Collaborate cross-functionally with Quality, Manufacturing, and Regulatory teams to implement compliant solutions.
Qualifications & Experience:
- Bachelor's degree in Engineering or Quality-related discipline.
- 25 years of experience in medical device manufacturing, quality, or remediation projects.
- Strong knowledge of process validation (IQ/OQ/PQ) and CAPA/NCR management.
- Proven technical writing and documentation skills.
- Familiarity with 21 CFR Part 820 and ISO 13485 quality standards.
- Excellent problem-solving skills with the ability to take a problem statement through to a compliant solution.
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