- 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.
- Robust understanding of ISO 13485:2016 standard and FDA regulations (CFR).
- Proven track record in auditing, CAPA implementation, risk management, and supplier quality assurance.