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

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