Quality Assurance Manager

Roles and Responsibilities :

• Ensure compliance with quality systems, regulations, and industry standards for medical devices and equipment.
• Conduct audits, identify areas for improvement, and implement corrective actions to maintain high-quality products.
• Collaborate with cross-functional teams to develop and implement risk management plans to mitigate potential issues.
• Develop and execute supplier quality assurance programs to ensure timely delivery of components meeting required specifications.

Job Requirements :

• 7-15 years of experience in Quality Assurance Manager role within the Medical Devices & Equipment industry.
• Strong understanding of ISO 13485:2016 standard and FDA regulations (CFR).
• Proven track record in auditing, CAPA implementation, risk management, and supplier quality assurance.