Quality Assurance Manager- IVD/Medical Device Manufacturing

Job Title: Quality Assurance (QA) Manager

Location: Sector 11, Noida, Uttar Pradesh

Experience Required: 510 years

Industry: In-Vitro Diagnostics (IVD) / Medical Device Manufacturing

About Avience Biomedicals Limited

Avience Biomedicals Limited has over 20 years of experience in molecular biotechnology, genomics and the IVD industry. We are among the leading manufacturers, suppliers and distributors of molecular diagnostics products in India.

Who Are We Looking For

We are looking for a highly skilled, detail-oriented and experienced QA professional who can lead and strengthen our Quality Assurance function. The ideal candidate must have a solid background in IVD/medical device manufacturing, strong understanding of regulatory requirements, and hands-on experience with QMS implementation.

You should be someone who:

• Is well-versed with ISO 13485, ISO 14971, GMP, ICMED and other relevant standards.
• Can independently manage documentation, audits, CAPA, risk management and compliance activities.
• Is proactive, organised and capable of collaborating with cross-functional teams including Production, R&D and Regulatory Affairs.
• Has strong communication skills and can drive a culture of quality across the organisation.

Job Summary

As a QA Manager at Avience Biomedicals, you will maintain and strengthen the Quality Management System (QMS), monitor regulatory compliance (ISO 13485, ISO 14971, MDR, ICMED, etc.), and support manufacturing and R&D teams in producing compliant IVD/medical devices. You will be responsible for documentation, validations, audits, CAPA management and continuous quality improvement.

Key Responsibilities

Implement and maintain the QMS as per ISO 13485 and other relevant standards.

Prepare, review, control and maintain SOPs, work instructions and quality documents.

Manage DMR, DHR and DHF documentation.

Conduct internal audits and support external audits by regulatory or certification bodies.

Manage CAPA, non-conformance, root cause analysis and change control.

Participate in risk management activities based on ISO 14971.

Review and approve validation protocols and reports (equipment/process/software).

Ensure compliance with GMP and regulatory requirements for IVD/medical devices.

Conduct QMS trainings for cross-functional teams.

Coordinate with R&D, production and regulatory teams for product development and quality improvements.

Required Skills & Competencies

Strong understanding of ISO 13485, ISO 14971, ICMED, MDR and GMP.

Hands-on experience with QMS implementation, documentation control and audits.

Knowledge of technical file preparation and regulatory submissions.

Excellent documentation, analytical and problem-solving abilities.

Educational Qualifications

B.Sc. / M.Sc. in Biotechnology, Microbiology or related Life Science fields

OR

B.Tech / M.Tech in Biomedical, Biotechnology