QA Associate/QA Manager (Pharma/Medical Devices)

Job Description: Key Responsibilities:

• Ensure product quality and adherence to regulatory standards, including EU MDR 2017/745 and ISO 13485:2016.
• Assist in the preparation and maintenance of quality manuals, formats, and standard operating procedures (SOPs) in line with industry standards.
• Conduct internal audits and assist with the documentation, reporting, and follow-up of audit findings.
• Support the investigation of complaints and the implementation of corrective and preventive actions (CAPAs).
• Prepare and maintain technical files, including Instructions for Use (IFUs), labeling, packaging information, and patient information leaflets.
• Review and verify certificates of analysis (COAs), sterilization check sheets, calibration reports, and other related documents for compliance.
• Oversee microbiological testing, water testing, media preparation, and instrument operation in quality control processes.
• Ensure compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and other relevant regulatory requirements.
• Assist in the preparation and maintenance of site master files and device master files in accordance with regulatory guidelines, including Indian MDR.
• Participate in management review meetings and contribute to discussions on quality performance and regulatory compliance.
• Stay informed about changes to regulatory requirements, particularly in relation to EU MDR and ISO standards.
• Support the preparation of clinical evaluation reports, risk management analyses, and other regulatory documents.
• Conduct training sessions on quality-related topics, SOPs, and compliance requirements.
• Provide support in the maintenance and updating of quality control documentation, including testing records and procedural updates.

1. Bachelor’s degree in Life Sciences, Engineering, or a related field, with experience in medical device regulations (EU MDR, ISO 13485) and regulatory documentation.
2. Knowledge of quality management systems, cGMP/GLP practices, and strong understanding of quality assurance processes, including complaint handling, CAPAs, and internal auditing.
3. Excellent organizational, analytical, and problem-solving skills, with strong written and verbal communication abilities.
4. Ability to work independently and collaboratively in a team environment; experience in microbiological testing and quality control procedures is a plus.