Job Description

JobResponsibilities

• Develop, implement, and maintain quality management systems (QMS) in compliance with ISO 13485, FDA, and other applicable regulations.
• Lead, mentor, and manage a team of quality assurance professionals.
• Oversee internal and external audits, including preparation, execution, and corrective action follow-up.
• Review and approve quality documentation, including SOPs, batch records, CAPAs, and deviation reports.
• Collaborate with R&D, Manufacturing, Regulatory, and Operations teams to ensure product quality from development to commercial release.
• Monitor key quality metrics and drive continuous improvement initiatives.
• Ensure timely response to customer complaints, non-conformances, and regulatory inspections.
• Lead risk management initiatives and support product change controls.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
• 8+ years of experience in quality assurance, with at least 3 years in a leadership role within the medical device, pharmaceutical, or biotech industry.
• In-depth knowledge of FDA, ISO 13485, and other applicable quality regulations.
• Strong leadership, coaching, and team development skills.
• Excellent analytical, problem-solving, and communication skills.
• Proven experience with audits, CAPAs, risk management, and compliance documentation.

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