Senior Quality Assurance Specialist

1 day ago


faridabad, India beBeeRegulatory Full time

Job Title: Senior Quality Assurance SpecialistRole Overview:We are seeking an experienced and skilled Senior Quality Assurance Specialist to lead our quality management system in medical device manufacturing. The ideal candidate will have a strong understanding of regulatory standards, such as ISO 13485, and be able to ensure product quality, process integrity, and audit readiness.Key Responsibilities:Oversee incoming, in-process, and final product inspections to guarantee compliance with regulatory requirements.Ensure adherence to ISO 13485, ISO 14971, and GMP guidelines through regular audits and documentation reviews.Manage deviations, CAPA, and root cause analysis to identify and implement corrective actions.Support the validation and qualification of equipment and processes to maintain quality standards.Lead internal and supplier audits, as well as support regulatory inspections to demonstrate compliance.Drive continuous improvement initiatives in quality systems to enhance efficiency and effectiveness.Qualifications:Bachelor's or Master's degree in a relevant field, such as biomedical engineering, biotechnology, or life sciences.A minimum of six years' experience in quality assurance and control within medical device manufacturing.Strong understanding of QMS documentation and validation protocols.Internal auditor certification, preferably ISO.



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