Quality Assurance Operations Specialist

JOB TITLE: Quality Assurance Operations Specialist

• Department: Quality Assurance
• Reports to: VP - QARA
• Experience : 2 to 5 years in medical devices
• Location: Onsite – 5 days a week (Malleshwaram)
• Qualification : Bachelor’s degree in Engineering, Sciences, or Pharma
• Employment Type: Full-time

ROLE OVERVIEW

The Quality Assurance Operations Specialist will be responsible for day-to-day quality operations and QMS execution across hardware manufacturing and production activities. This role is highly hands-on and works closely with Production, Quality Control, R&D, and Regulatory Affairs teams to ensure compliance with ISO 13485:2016, GMP, and applicable regulatory requirements.

The role focuses on streamlining production processes, maintaining documentation discipline, supporting audits, and ensuring consistent quality compliance across the product lifecycle.

KEY RESPONSIBILITIES

Quality Management System (QMS)

• Establish, maintain, and continuously update the Quality Management System (QMS) in compliance with ISO 13485:2016 and applicable regulatory requirements.
• Prepare, review, approve, and control:
• Quality Manual
• Standard Operating Procedures (SOPs)
• Work Instructions (WIs)
• Formats, templates, and quality records
• Ensure effective document control, version management, archival, and change control within the QMS.

Production & Operational Quality

• Work closely with Hardware, Manufacturing, and Production teams to:
• Implement ISO 13485-compliant processes
• Improve shopfloor quality practices
• Ensure documentation discipline in daily operations
• Generate, review, and approve DHR, DoC and batch release documentation in accordance with approved specifications.
• Ensure compliance with GMP requirements, applicable standards, and internal procedures.
• Support material, in-process, and finished product quality documentation.

Change, Deviation & CAPA Management

• Implement and manage:
• Change control processes
• Deviation management
• Non-conformance handling
• Corrective and Preventive Actions (CAPA)
• Track investigations, root cause analysis, effectiveness checks, and timely closure of actions.
• Ensure proper impact assessment of changes on quality, regulatory, and production processes.
• Conduct internal audits and ensure ongoing readiness for external audits.

Cross-Functional Collaboration

• Coordinate with Production, QC, Regulatory Affairs, R&D, and Supply Chain teams to ensure:
• Quality compliance across the product lifecycle
• Alignment between procedures and actual shopfloor practices
• Support continuous improvement initiatives in manufacturing and quality operations.

BEHAVIORAL COMPETENCIES

• Detail-oriented with strong documentation discipline
• Practical, shopfloor-friendly approach to quality
• Good communication and stakeholder coordination skills
• Ability to handle multiple operational priorities
• Proactive and solution-oriented mindset