We are looking for a qualified professional to join a Medical Device & Disposable Manufacturing Company. The candidate will be responsible for ensuring product quality, regulatory compliance, process validation, auditing, and controlled documentation in accordance with applicable national and international medical device regulations.
Required Skills & Knowledge
- Proficiency in MS Office
- Working knowledge of ISO 13485 – Quality Management Systems for Medical Devices
- Knowledge of EU Medical Device Regulation (MDR) 2017/745 and applicable amendments
- Knowledge of 21 CFR Part 820 – Quality System Regulation
- Understanding of applicable CDSCO, FDA, and CE regulatory requirements
- Strong documentation and compliance skills
Key Job Responsibilities
Quality & Regulatory Compliance
Ensure medical devices and disposable products comply with applicable government and international regulatory requirements, including CDSCO, FDA, CE, ISO 13485, and EU MDR.
Review quality and regulatory requirements and ensure compliance throughout the manufacturing process.
Support implementation and maintenance of quality systems and regulatory procedures.
Process Validation
- Coordinate with the Manufacturing Engineering (ME) team for machine and process trials.
- Prepare, review, and maintain process and equipment validation protocols and reports.
- Ensure validation activities are conducted and documented according to approved procedures and regulatory requirements.
Auditing
- Coordinate and support internal and external audits at the manufacturing facility.
- Prepare required documentation and records for audits.
- Assist in addressing audit observations, implementing corrective actions, and maintaining compliance.
Documentation & Quality Records
- Review, approve, and maintain Master Formula Records (MFR) and Batch Manufacturing Records (BMR).
- Ensure quality documentation is accurate, complete, traceable, and maintained as per applicable procedures.
- Maintain proper records to support regulatory inspections and quality audits.