Role Overview:
The QA Manager will be responsible for managing Quality Assurance and documentation activities in a medical device manufacturing environment. The role focuses on ensuring compliance with ISO 13485, CDSCO regulations, and GMP standards, while supporting production and maintaining a robust Quality Management System (QMS).
Key Responsibilities:
· QMS Documentation (ISO 13485): Prepare, review, and control SOPs, formats, DHR, protocols, and records ensuring compliance with ISO 13485.
· Batch Record Review: Review BMR/DHR for completeness, traceability, and compliance prior to product release.
· Deviation & CAPA Management: Initiate, investigate, and close deviations and implement CAPA as per ISO 13485.
· Line Clearance & Shopfloor QA: Perform line clearance and ensure adherence to cleanroom and medical device manufacturing practices.
· Audit & Compliance Support: Support internal, external, and regulatory audits and ensure timely closure of observations.
· Regulatory Compliance: Ensure compliance with CDSCO, ISO 13485, and GMP requirements and assist in regulatory documentation.
Key Skills & Competencies:
· Strong knowledge of ISO 13485 and medical device QMS
· Understanding of CDSCO regulations for medical devices
· Experience in medical device manufacturing environment
· Knowledge of GMP, cleanroom practices, and documentation control
· Strong attention to detail and problem-solving skills
Preferred Attributes:
· Experience in Class B / Class C medical devices
· Exposure to validation, risk management, and design control
· Ability to work cross-functionally with production, QC, and regulatory teams
Job Type: Full-time
Pay: From ₹300,000.00 per year
Benefits:
Experience:
- QA/QC: 2 years (Required)
Work Location: In person
