Quality Auditor
1 month ago
We are seeking a meticulous and experienced GMP Auditor to ensure compliance with Good Manufacturing Practices (GMP) within our medical device operations. This role is integral to maintaining the highest standards of quality, safety, and regulatory compliance for our products. The GMP Auditor will assess manufacturing processes, perform audits, and provide actionable recommendations to align operations with industry standards and regulatory requirements.
Key Responsibilities
Auditing and Compliance
- Plan, schedule, and conduct internal and external GMP audits of medical device manufacturing facilities, suppliers, and service providers.
- Verify compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and other applicable regulations and standards.
- Evaluate processes, documentation, and systems to identify non-conformances and areas for improvement.
- Collaborate with cross-functional teams to address corrective and preventive actions (CAPAs) resulting from audit findings.
Documentation and Reporting
- Prepare detailed audit reports, including findings, risk assessments, and recommendations for corrective actions.
- Maintain accurate and organized audit records and documentation to ensure traceability and regulatory readiness.
- Support management reviews by presenting audit results and trend analyses.
Regulatory Support
- Provide expertise during regulatory inspections and support responses to regulatory bodies.
- Monitor updates in GMP regulations and industry standards, advising the organization on necessary changes to policies or procedures.
Training and Guidance
- Train employees and suppliers on GMP requirements and best practices for medical device manufacturing.
- Act as a resource for quality and compliance queries, fostering a culture of quality throughout the organization.
Qualifications
Education
- Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related field. Advanced degree preferred.
Experience
- 5+ years of experience in quality assurance, auditing, or compliance within the medical device industry.
- Proven experience conducting GMP audits.
Certifications
- Auditor certifications such as Lead Auditor for ISO 13485, CQE (Certified Quality Engineer), or CQA (Certified Quality Auditor) preferred.
Skills and Competencies
- Strong understanding of GMP principles, ISO 13485, FDA regulations, and other relevant standards.
- Excellent analytical and problem-solving skills.
- Exceptional attention to detail and organizational abilities.
- Effective communication skills, both written and verbal, to articulate findings and recommendations clearly.
- Ability to work independently and collaboratively in a fast-paced environment.
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