Key Responsibilities

- Lead the effective implementation, maintenance and compliance of the site QMS.

- Ensure compliance with ISO 13485:2016, ISO 15378:2017, ISO 9001:2015 and 21 CFR 820 requirements.

- Drive NPI quality and regulatory compliance, including review and approval of verification and validation records.

- Maintain QMS integrity during process, equipment and organizational changes.

- Ensure compliance with GMP, regulatory and customer requirements.

- Drive deviation, non-conformity, RCA, CAPA and change control activities.

- Conduct and manage internal, external, customer and regulatory audits and ensure timely closure of findings.

- Monitor CAPA effectiveness and conduct process audits.

- Handle customer complaints, market feedback and quality incidents.

- Manage quality risk management activities.

- Lead supplier quality management, including supplier audits, supplier performance, raw/packing material quality and SCAR-related activities.

- Support validation and qualification activities for processes, equipment and systems.

- Ensure cleanliness, contamination control, hygiene and GMP requirements.

- Conduct quality-related training and develop team competency.





- Lead Management Review activities and monitor QMS objectives, KPIs, audits, CAPA and compliance.

- Coordinate with Corporate Quality and cross-functional teams for quality improvement initiatives.

- Lead and develop the Quality team and ensure effective execution of site quality activities.

Key Requirements

- 10+ years of experience in Quality Assurance / QMS with at least 2 years in a managerial role.

- Experience in medical devices and/or pharmaceutical primary packaging is preferred.

- Solid knowledge of ISO 13485, ISO 15378 and ISO 9001.

- Experience with GMP/GDP, FDA/EU regulatory requirements and 21 CFR 820.

- Experience in CAPA, RCA, deviations, change control, audits, risk management and validation/qualification.

- Experience in supplier quality, supplier audits and SCAR.

- Exposure to molding/assembly and cleanroom manufacturing will be preferred.

- ISO 13485/ISO 15378 Lead Auditor certification and Six Sigma Green/Black Belt will be an advantage.

- Good knowledge of ERP systems and strong leadership, communication and cross-functional coordination skills.

Interested candidate can apply [email protected]

📌 Quality Assurance Manager (Bengaluru)
🏢 BVR People Consulting
📍 Bengaluru