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:

- Commuter assistance

Experience:

- QA/QC: 2 years (Required)

Work Location: In person

📌 QA Manager (India)
🏢 CURO Biosciences
📍 India