Job Description

Job Title: Quality Assurance Engineer (Medical Devices) - ISO & MDSAP

Location:

Tajpur Road, Changodar, Gujarat

Job Type:

Full-time

Experience:

3-8 years

Industry:

Medical Devices Manufacturing

About the Role

We are seeking a highly skilled

Quality Assurance Person

with strong experience in the

Medical Device Manufacturing Industry

, including expertise in

ISO 13485

,

MDSAP

, and regulatory compliance. The ideal candidate will support QA activities across the product lifecycle, ensure quality system adherence, and drive continuous improvement initiatives in accordance with global medical device standards.

Key Responsibilities

Implement, maintain, and improve the

Quality Management System (QMS)

in compliance with

ISO 13485

,

MDSAP

, and applicable regulatory requirements. Support internal and external audits, including

Notified Body

,

MDSAP

, and customer audits. Review and approve quality documentation such as SOPs, work instructions, protocols, reports, and validation records. Manage nonconformities, CAPA, change control, and risk management activities. Ensure compliance throughout design, manufacturing, testing, and post-market phases. Collaborate cross-functionally with R&D, Manufacturing, Regulatory, and Operations teams to ensure product quality. Participate in supplier qualification, audits, and ongoing supplier quality monitoring. Maintain thorough documentation and support regulatory submissions when needed.

Required Qualifications & Skills

Bachelor's degree

3+ years of experience

in

Quality Assurance

within the Plastic/Silicone/Metal

Medical Device

Manufacturing Industry. Strong knowledge of

ISO 13485

,

MDSAP

, and medical device regulatory requirements (FDA 21 CFR Part 820 preferred). Experience with CAPA, NCR, audits, document control, and risk management (ISO 14971). Excellent understanding of QMS processes and quality engineering principles. Strong analytical, documentation, and communication skills. Ability to collaborate effectively across teams and work in a fast-paced environment.

Preferred Qualifications

Experience with product validation and verification activities. Exposure to EU MDR / FDA regulatory landscapes. Six Sigma, Lean, or Quality-related certifications.

Benefits

Competitive salary and performance incentives Health insurance and employee wellness benefits Opportunity to work with global teams in the medical device industry Professional development and career growth opportunities

How to Apply

Please submit your resume along with a brief cover letter outlining your relevant experience.

Job Types: Full-time, Permanent

Pay: ₹180,137.44 - ₹720,925.77 per year