Quality Assurance Manager

Job Description

Quality Assurance Manager (Medical Devices)

Job Location: Chennai

They should also possess excellent documentation and validation knowledge to ensure compliance with regulatory standards.

• Develop and implement quality assurance strategies and processes to ensure compliance with CE, US FDA, and EU MDR regulations.
• Establish and maintain quality management systems to support product development, manufacturing, quality and distribution processes.
• Conduct audits and inspections to ensure adherence to regulatory requirements and medical quality standards.
• Provide guidance and training to employees regarding quality assurance procedures, regulations, and documentation requirements.
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality is built into product development and manufacturing processes.
• Lead risk management activities and ensure appropriate mitigation measures are in place.
• Oversee the validation of manufacturing and sterilization processes.
• Manage the documentation process, including the creation, review, and approval of quality-related documents, such as standard operating procedures (SOPs), work instructions, and validation protocols.
• Monitor and analyze quality metrics to identify trends, implement corrective actions, and drive continuous improvement.
• Serve as the primary point of contact for regulatory agencies during inspections and audits.
• Stay up to date with evolving regulations, industry standards, and best practices related to medical device quality assurance.
• Responsible for Quality Assurance Documentation and quality of the products for product release.

• Bachelor's / Master's degree / Ph.D. in biotechnology and/or a relevant experience in the scientific field.
• 7-10 years of experience in quality assurance within the medical device industry.
• In-depth knowledge of ISO 13485, Indian MDR, CE, US FDA, and EU MDR regulations.
• Experience in Applicable Product Standards in ISO / ASTM / USP.
• Strong leadership skills with the ability to influence and collaborate across teams.
• Excellent communication and interpersonal skills.
• Detail-oriented with strong analytical and problem-solving abilities.
• Handling audits related to State FDA, CDSCO, CE Marking, US FDA 510K, MDSAP, and Notify body for QMS/ MDR.

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