Senior Executive Quality Assurance

Key Responsibilities:

• Lead preparation and implementation of ISO 13485, MDSAP, and 21 CFR Part 820 compliance.
• Manage the preparation of the Design Dossier along with other documents and ensure compliance with EU MDR requirements.
• Conduct gap analysis of client QMS and MDD/MDR documentation.
• Draft, review, and approve stability study protocols, reports, and validation documentation.
• Organise and oversee Internal Quality Audits (IQA) and Management Review Meetings (MRMs).
• Plan and execute predefined visits based on client needs and predetermined agendas.
• Conduct internal audits of systems and processes to identify non-conformances and drive closure.
• Update technical documentation (CER, PSUR, PMCF) on an annual basis.
• Monitor quality objectives and provide reports on performance and improvements.
• Prepare clients for recertification and surveillance audits with necessary documentation and training.
• Perform data analysis and recommend process improvements for manufacturing and compliance.
• Conduct training programs to enhance employee awareness and regulatory compliance culture.
• Verify record-keeping practices across departments for accuracy and effectiveness.
• Provide expert consultation to clients on Good Manufacturing Practices (GMP) and overcoming manufacturing challenges.
• Act as the primary liaison with clients, auditors, and regulatory bodies during inspections and audits.

Qualifications & Experience:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field.
• Minimum 2-3 years of experience in Quality Assurance
• Strong knowledge of ISO 13485, MDSAP, 21 CFR Part 820, EU MDR, and related standards.
• Proven experience in audit preparation, documentation, closure of non-conformances and CAPA
• Hands-on experience in drafting technical files, CER, PSUR, and PMCF reports.
• Excellent communication, leadership, and client management skills.

Key Competencies:

• Strong analytical and problem-solving skills.
• Attention to detail with a structured and methodical approach.
• Ability to manage multiple client projects simultaneously.
• Leadership qualities with team mentoring and client-handling skills.
• Commitment to continuous improvement and regulatory excellence.

Job Location: Makarba, Ahmedabad