Quality Assurance Operations Specialist Jobs | Medical Devices QA Careers
Quality Assurance Operations Specialist Jobs offer an excellent opportunity for professionals seeking stable and growth-oriented Pharma Jobs in the medical devices sector. This role focuses on hands-on quality operations, QMS execution, and ISO 13485 compliance, making it ideal for experienced candidates aiming to strengthen their careers in quality assurance and regulatory compliance.
Job Details
- Job Title: Quality Assurance Operations Specialist
- Location: Onsite – 5 days a week (Malleshwaram)
About the Company
The organization operates in the medical devices domain and follows strict regulatory and quality compliance standards. It emphasizes ISO 13485:2016, GMP, and robust Quality Management Systems to ensure product safety, performance, and regulatory adherence across the product lifecycle.
Job Description
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 and 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, and 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.
- Ensure alignment between procedures and actual shopfloor practices.
- Support continuous improvement initiatives in manufacturing and quality operations.
Qualifications
- Bachelor’s degree in Engineering, Sciences, or Pharma
- 2 to 5 years of experience in medical devices
- Strong understanding of ISO 13485:2016, GMP, and QMS execution, Ideal for Pharma Jobs.
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
