Quality Assurance Executive

Job Title: Quality Assurance (QA) Executive
Location: Sector 11, Noida, Uttar Pradesh
Experience Required: 5–10 years
Industry: In-Vitro Diagnostics (IVD) / Medical Device Manufacturing
Department: Quality Assurance

About Avience Biomedicals Limited:
Avience Biomedicals Limited has over 20 years of experience in molecular biotechnology, genomics and the IVD business. It is among the well-known manufacturers, suppliers and distributors of molecular diagnostics products in India. The company develops innovative, broadly-applicable solutions and works to provide affordable options for rural and under-privileged populations.

Job Summary:
As a QA professional at Avience Biomedicals, you will ensure compliance with regulatory standards (ISO 13485, ISO 14971, MDR, ICMED, etc.), maintain the Quality Management System (QMS), and support the manufacturing and R&D teams in producing IVD/medical devices. Your role will include documentation, audits, validations, and regulatory compliance across the organisation.

Key Responsibilities:

• Implement and maintain the QMS in line with ISO 13485 and other relevant standards.
• Prepare, review, control and maintain SOPs, work instructions and quality records.
• Manage product documentation including Device Master Records (DMR), Device History Records (DHR) and Design History Files (DHF).
• Conduct internal audits and support external/regulatory audits (e.g., by certification bodies or regulatory agencies).
• Manage Corrective and Preventive Actions (CAPA), non‐conformance reports and change control processes.
• Participate in risk management activities in accordance with ISO 14971.
• Review and approve validation protocols and reports (equipment, process, software).
• Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements applicable to IVD/medical devices.
• Conduct training programmes on QMS and quality procedures for cross‐functional teams.
• Coordinate with R&D, production and regulatory teams for product development, launch and continuous quality improvement.

Required Skills & Competencies:

• Strong knowledge of ISO 13485, ISO 14971, EU MDR (if applicable), ICMED and GMP for IVD/medical device manufacturing.
• Demonstrated experience with QMS implementation, documentation control and audits.
• Familiarity with regulatory submissions, technical file preparation for IVD/medical devices.
• Excellent documentation, analytical and problem-solving skills.
• Proficiency in MS Office and familiarity with electronic documentation/document control systems.
• Strong communication and team coordination skills.

Educational Qualification:

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

OR

• B.Tech / M.Tech in Biomedical / Biotechnology / Mechanical Engineering

Job Type: Full-time

Pay: ₹360,000.00 - ₹720,000.00 per year

Application Question(s):

• What is your current monthly salary?
• What is your expected monthly remuneration?
• What is your Notice Period?

Location:

• Noida, Uttar Pradesh (Preferred)

Work Location: In person