Lead - Quality Assurance Management

4 days ago

vellore, India beBeeQuality Full time

Senior Quality Systems LeadA well-established medical devices manufacturer is seeking a senior quality systems professional to lead its organisation-wide quality management system function.The successful candidate will oversee the QMS and ensure it consistently meets global regulatory requirements by strengthening compliance frameworks, improving documentation systems, managing audits, driving supplier quality governance, and ensuring international medical device standards are met.Key responsibilities include maintaining documentation integrity, record-keeping systems, version control, and regulatory traceability; evaluating and developing suppliers through audits, SCAR/CAPA follow-up, and performance tracking; and collaborating with cross-functional teams to close gaps and enhance system robustness.Preferred qualifications include deep expertise in CAPA/RCA, complaint handling, post-market surveillance, supplier quality, and audit management; understanding of ISO 13485, MDR, MDSAP, FDA QSR, and documentation control systems; and lead auditor certifications.Key Requirements:Expertise in quality systems, including ISO 13485, MDR, and FDA QSR;Strong leadership skills, with experience in managing cross-functional teams;Excellent communication and problem-solving skills;Ability to work in a fast-paced environment and meet deadlines;Understanding of regulatory requirements and industry standards;Experience with documentation control systems, version control, and regulatory traceability.

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