Quality Assurance Executive

Job Title: Senior QARA Executive

No of Vacancy: 1

Job Location: Mira Road/Boisar

Years of Experience: 4-8

Working Days:Monday to Saturday

Job Summary:

The Senior Executive QARA will be responsible for ensuring compliance with ISO 13485, Medical Device Rules (MDR 2017), and other applicable global regulatory requirements. The role involves managing quality systems, supporting regulatory submissions, and ensuring continuous improvement in product quality and compliance.

Key Responsibilities:

Quality Assurance:

Implement and maintain QMS in compliance with ISO 13485 and 21 CFR Part 820 (if applicable).

Prepare, review, and control SOPs, Quality Manuals, and Work Instructions.

Manage and monitor CAPA, Deviations, Non-Conformances, and Change Control activities.

Conduct and support internal audits, supplier audits, and ensure closure of audit findings.

Oversee document control and record management.

Support in validation and qualification of equipment, processes, and software as per QMS.

Ensure proper control of incoming materials, in-process, and finished product inspection.

Regulatory Affairs:

Prepare and compile Regulatory Dossiers for product registration (Form MD-5/MD-9, MD-14, etc.) under MDR 2017.

Liaise with Notified Bodies, State Licensing Authorities, and CDSCO for product approvals and licensing.

Maintain and update Technical Files, Risk Management Files, and Clinical Evaluation Reports as per ISO 14971 and ISO 10993.

Ensure labeling and packaging compliance with applicable regulatory requirements.

Support post-market surveillance (PMS) and vigilance activities.

Additional Responsibilities:

Participate in management reviews, quality improvement projects, and training programs.

Collaborate with R&D, Production, and Supply Chain teams to ensure regulatory and quality compliance throughout product lifecycle.

Stay updated on regulatory changes and ensure timely implementation within the organization.

Educational Qualifications:

Bachelor's and/or Master's degree in Pharmaceutical Sciences, Engineering, Biotechnology, Microbiology, or a related life science discipline

Preferred specialization in Regulatory Affairs or Quality Assurance

Key Skills & Competencies:

Excellent scientific writing, documentation, and presentation skills

In-depth knowledge of ISO 13485, 21 CFR Part 820, and Schedule V of MDR 2017

Understanding of MDSAP and other global quality standards (preferred)

Hands-on experience in:

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Familiarity with data analysis and reporting tools

People management and team coordination experience (preferred)

Monday to Saturday working

Company Website:

https://www.laxmidentallimited.com/

https://www.illusiondentallab.com/

https://www.illusionaligners.com/