Key Responsibilities :
- Conduct audits of manufacturing processes, facilities, and documentation related to biologics and tissue within the medical device industry.
- Evaluate compliance with regulatory requirements, including FDA regulations and ISO standards, as applicable to biologics and tissue.
- Assess the quality management systems (QMS) and identify areas for improvement to ensure continuous compliance and operational efficiency.
- Collaborate with cross-functional teams to address audit findings and implement corrective and preventive actions (CAPAs) as necessary.
- Generate comprehensive audit reports documenting findings, observations, and recommendations for management review.
- Stay updated on industry regulations, guidelines, and best practices related to biologics and tissue to inform audit processes and ensure compliance.
Mandatory Requirements :
- Bachelor's degree in a relevant field
- Must be ex-FDA
- Minimum 10+ years of experience in auditing within the medical device industry, with a focus on biologics and tissue.
- In-depth knowledge of regulatory requirements, including FDA regulations (e.g., 21 CFR Part 820) and ISO standards (e.g., ISO 13485)
- Certification as a Quality Auditor (e.g., ASQ Certified Quality Auditor) or equivalent professional certification.
- Proven track record of conducting effective audits and generating detailed audit reports.
- Strong analytical skills and attention to detail in assessing compliance and identifying areas for improvement.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
1 week audit in December in Massachusetts
Biologics Auditor
Conduct audits of manufacturing processes, facilities, and documentation related to biologics and tissue within the medical device industry. Evaluate compliance with regulatory requirements, including FDA regulations and ISO standards, as applicable to biologics and tissue. Stay updated on industry ...
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