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
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