We are looking for a QA Supervisor (Contractual) to lead and strengthen our Quality Management System (QMS), ensuring compliance with global medical device regulations while supporting commercial sales, distribution networks, and service operations across India
Location: Gurgaon (India)
Function: Quality Assurance
Reports To: Sr. QA Manager
Key Responsibilities
Manage and continuously improve the QMS in line with ISO 13485, FDA QSR, MDR/IVDR and other regulatory requirements.
Lead audits, CAPA management, compliance initiatives, and quality improvement programmes.
Oversee quality controls across direct sales, distributors, service centres, and repair operations.
Drive complaint handling, post-market surveillance, non-conformance investigations, and supplier quality management.
Collaborate with cross-functional teams to ensure quality is embedded across the product lifecycle.
What We're Looking For
Bachelor's degree in Engineering, Life Sciences, Quality or related field.
2+ years of Quality Assurance experience in the Medical Device industry.
Robust working knowledge of ISO 13485, FDA QSR, CAPA, audits, complaints handling, and regulatory compliance.
Experience supporting distribution networks and/or service & repair operations.
Preferred Qualifications
ASQ CQE/CQA or equivalent certification.
Experience with EU MDR and APAC regulations.
Exposure to ERP/eQMS platforms such as Oracle, Agile, or TrackWise.
Knowledge of ISO 14971 Risk Management.
Interested candidates can apply or share their profiles at
[email protected] or connect at (phone hidden)
📌 QA Supervisor (Contractual) (Gurugram)
🏢 Career Point
📍 Gurugram