Kochi, Kl Qa process executive Jobs – 5 Open Jobs Today

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Quality Assurance Executive – Quality Management System

Gadgeon Medical Systems Pvt Ltd.
Kochi, Kerala

Quick apply

Job details

Permanent | Full-time
₹25,000 - ₹40,000 a month

Benefits

Provident Fund
Paid time off

Qualifications

Microsoft Office
Minitab
Quality assurance
Bachelor's degree
EMR systems
Document management
Communication skills
FDA regulations

Full job description

QA Executive – Quality Management System (QMS)

Department: Quality Assurance

Reporting To: QA RA Specialist

Experience:2–5 Years

Industry: Medical Devices / Electronic Medical Devices

Standard: ISO 13485:2016

Job Summary

We are looking for a detail-oriented and compliance-driven QA Executive – QMS to join our Quality Assurance team. The ideal candidate will be responsible for implementing, maintaining, and continuously improving the Quality Management System (QMS) in accordance with ISO 13485:2016 and applicable medical device regulations.

This role involves handling document control, internal audits, CAPA, non-conformance management, complaint handling, and supporting regulatory compliance activities to ensure the delivery of safe and effective medical devices.

Key Responsibilities

Maintain and improve the Quality Management System (QMS) as per ISO 13485:2016 requirements
Manage document control activities including SOPs, formats, records, and revisions
Conduct and support internal audits and follow-up actions
Handle Non-Conformances (NC), CAPA, deviations, and complaint investigations
Perform root cause analysis using tools such as 5-Why, Fishbone/Ishikawa, and FMEA
Support regulatory compliance activities related to CDSCO, EU MDR, and FDA requirements
Collaborate with cross-functional teams including R&D, Manufacturing, and Regulatory Affairs
Ensure proper maintenance of quality records and audit readiness
Participate in continuous improvement initiatives and quality training activities

Qualifications

BE/BTech in Biomedical Engineering, Life Sciences, or related field
2–5 years of experience in Quality Assurance / Regulatory Affairs within the medical device industry
Experience in electronic medical devices is mandatory
Good understanding of ISO 13485:2016 requirements

Exposure to:

US FDA 21 CFR Part 820
CDSCO Medical Device Rules 2017
EU MDR 2017/745
ISO 13485 Internal Auditor certification will be an added advantage

Required Skills

Strong knowledge of document control processes
Experience in handling NC, CAPA, and complaint management
Familiarity with risk management concepts (ISO 14971)
Awareness of IEC 62304 medical device software lifecycle standards is preferred
Strong written communication skills for SOPs, audit reports, and regulatory documentation
Good analytical and problem-solving abilities
Attention to detail and strong compliance mindset
Proficiency in MS Office; knowledge of Minitab or statistical tools is a plus

Desirable Add-ons

Candidates with exposure to below will be given preference

Sterile device manufacturing
Electronic medical devices
Combination products
CDSCO QMS inspection requirements

Pay: ₹25,000.00 - ₹40,000.00 per month

Benefits:

Paid time off
Provident Fund

Application Question(s):

Current CTC
Expected CTC
Do you have experience in electronic medical devices?
Do you have BE/BTech in Biomedical Engineering, Life Sciences, or related field?

Education:

Bachelor's (Required)

Experience:

QA: 2 years (Required)

Work Location: In person

Quick apply

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