Quality Assurance Manager

BVR People Consulting; Bengaluru; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

BVR People Consulting is seeking a senior Quality Assurance leader in Bengaluru, India to lead the site QMS, ensure compliance with ISO standards and 21 CFR 820, and drive CAPA, audits and continual improvement. The role emphasizes NPI quality, supplier quality and cross-functional coordination in a GMP environment.

We look for 10+ years in QA/QMS, with managerial experience and certifications like ISO 13485 Lead Auditor and Six Sigma.

Qualifications

• 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.
• Strong 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.

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.

Skills

Quality Assurance

QMS

Leadership

Regulatory compliance

Audits

CAPA

Process improvement

Education

ISO 13485 Lead Auditor

Six Sigma Green/Black Belt

Tools

ERP systems

Job description

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.
  
• Strong 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.