Job Description :

- Implement a comprehensive quality management system (QMS) to ensure compliance with applicable regulations and standards, such as ISO 13485 and MDR (India) 2017 requirements.

- Manage the day-to-day operations of the quality control and quality assurance departments.

- Conduct regular inspections, audits, and assessments to monitor and evaluate the eectiveness of quality processes and procedures.

- Establish and maintain quality control documentation, including standard operating procedures (SOPs), work instructions, and quality records.

- Coordinate with cross-functional teams to ensure proper implementation of quality control measures throughout the product lifecycle, from design and development to manufacturing and distribution.

- Oversee the investigation and resolution of quality-related issues, non-conformities, and customer complaints, implementing corrective and preventive actions as necessary.

- Stay updated on relevant regulatory requirements, industry standards, and best practices to ensure compliance in all aspects of product manufacturing, labelling, and documentation.

- Prepare and submit regulatory submissions, technical files, and other documentation required for product approvals and registrations.

- Serve as the primary point of contact for regulatory agencies and notified bodies, addressing inquiries, inspections, and audits including external audits.

- Collaborate with R&D, manufacturing, and marketing teams to ensure new product development and launches comply with regulatory and quality requirements.

- Conduct training programs and provide guidance to employees on quality systems, regulatory compliance, and best practices.

- Manage the proper documentation and coordinate quality control for incoming raw material and outgoing finished goods.

- Maintain all quality related records.

Qualications & requirements :

- Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.

- Minimum of 3-4 years of experience in a quality control/assurance or regulatory aairs role within the medical device or IVD industry.

- In-depth knowledge of quality management systems, regulatory requirements, and standards relevant to IVD instruments and reagents, such as ISO 13485 and MDR (India) 2017.

- Strong understanding of quality control principles, statistical analysis, and continuous improvement methodologies.

- Experience in managing regulatory submissions and interactions with regulatory agencies.

- Excellent communication skills, both verbal and written, with the ability to eectively interact with internal teams, external stakeholders, and regulatory authorities.

- Detail-oriented mindset with strong analytical and problem-solving abilities.

- Ability to lead and motivate a team, ensuring collaboration, accountability, and a culture of quality excellence.

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