Head Quality Assurance

*Job Title:* QA Head Pharmaceutical & Surgical Division

*Company:* Neptune Orthopaedics Pvt. Ltd.

*Location:* Ahmedabad, Gujarat

*Experience Required:* Minimum 15 years

*Industry:* Medical Devices / Pharmaceuticals / Healthcare

*Functional Area:* Quality Assurance / Regulatory Affairs

The QA Head will be responsible for leading the Quality Assurance operations, ensuring compliance with national and international regulatory standards for medical device manufacturing. The role demands hands-on leadership in creating, implementing, and maintaining an ISO 13485-compliant Quality Management System (QMS).

*Key Responsibilities:*

- Lead and oversee QA functions for manufacturing and product quality compliance.

- Develop and maintain a robust QMS aligned with EN ISO 13485 and other regulatory guidelines.

- Ensure compliance with GMP, GTP, and other applicable norms for medical devices and pharmaceuticals.

- Conduct internal and external audits, CAPA reviews, and supplier quality assessments.

- Supervise validation and qualification protocols (process, equipment, and sterilization).

- Manage documentation and change control systems ensuring traceability and data integrity.

- Collaborate with R&D, Production, and Regulatory teams to ensure product conformance and continuous improvement.

- Engage with regulatory bodies during inspections and manage certification activities.

- Train QA team members on quality policies, standards, and procedures.

*Job Requirements*

- Bachelor’s/Master’s degree in Pharmacy, Biotechnology, or related discipline.

- Minimum 15 years of QA experience in the pharmaceutical and/or surgical/medical device sector.

- In-depth knowledge of EN ISO 13485, GMP, and other global medical device quality standards.

- Experience in handling audits (ISO, CE, CDSCO, etc.) and regulatory compliance documentation.

- Strong leadership, communication, and analytical skills.

- Proven ability to implement and maintain quality systems across production and operations teams.