Description

IntegriMedical Private Limited (IMPL) is a medical device manufacturing company. We manufacture global standard medical products used by Medical Practitioners (General & Specialists), Hospitals, Health Clinics working in different branches of medicines. Employees are the key to success in our organization. We value our employees and their skills in furthering the cause of helping lives. Thorough leadership, robust work planning methodology and exceptional customer service are the key enablers of our success. POSITION DESCRIPTION: IMPL is looking for a Manufacturing Quality Engineer, who will be responsible for ensuring that the products produced meet all regulatory, safety, and quality standards. This position combines aspects of engineering, quality management, and compliance within the highly regulated medical device sector (like ISO 13485, 21 CFR Part 820). POSITION RESPONSIBILITIES:  Ensure adherence to established QMS standards like ISO 13485, 21 CFR Part 820 (FDA regulations), and other relevant industry standards.  Support audits and inspections by regulatory bodies (e.g., FDA, I Support audits and inspections by regulatory bodies (e.g., FDA, ISO, and Notified Bodies).  Develop and maintain the documentation required for QMS (e.g., SOPs, work instructions, validation protocols).  Coordinate product testing and validation activities to confirm that medical devices meet specified requirements (e.g., design, performance, safety).  Lead or support process validation (e.g., IQ/OQ/PQ) for manufacturing processes to ensure they are capable of consistently producing quality products.  Oversee the identification, investigation, and resolution of non-conformances, deviations, and complaints.  Lead root cause analysis (RCA) efforts for product quality issues, ensuring corrective and preventive actions are implemented.  Apply risk management principles ((e.g., ISO 14971) to identify, assess, and mitigate risks throughout the product lifecycle.  Support risk assessments for new products or changes to existing products and processes. DESIRED/PREFERRED QUALIFICATIONS: • Any Graduate / Engineer or Master in Engineering, Science or Pharmacy • 0 to 3 years of Experience in working in quality domain • Working knowledge of FDA and other regulatory autho

Role and Responsibilities

• Ensure adherence to established QMS standards like ISO 13485, 21 CFR Part 820 (FDA regulations), and other relevant industry standards.  Support audits and inspections by regulatory bodies (e.g., FDA, ISO, and Notified Bodies).  Develop and maintain the documentation required for QMS (e.g., SOPs, work instructions, validation protocols).  Coordinate product testing and validation activities to confirm that medical devices meet specified requirements (e.g., design, performance, safety).  Lead or support process validation (e.g., IQ/OQ/PQ) for manufacturing processes to ensure they are capable of consistently producing quality products.  Oversee the identification, investigation, and resolution of non-conformances, deviations, and complaints.  Lead root cause analysis (RCA) efforts for product quality issues, ensuring corrective and preventive actions are implemented.  Apply risk management principles (e.g., ISO 14971) to identify, assess, and mitigate risks throughout the product lifecycle.  Support risk assessments for new products or changes to existing products and processes.