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Tier-1 brand but senior, onsite, and niche regulated skills limit applicant pool.
Regulatory validation and medical device standards heavily restrict cross-industry transferability.
Explicit 8+ years and mandatory regulated validation standards make filtering strict.
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Implement and execute policies, procedures, and quality processes that impact immediate organizational operations and foster efficiency and compliance.
Manage review, approval, and inspections of manufactured products, ensuring adherence to company standards and manufacturing specifications.
Lead and mentor quality assurance teams, oversee supplier quality management, and manage product recall procedures to ensure regulatory compliance.
Bachelor's or Master's Degree in Quality Management, Supply Chain Management, Engineering, Science or equivalent.
Minimum 8+ years experience in regulated industries including computer systems validation and security, with knowledge of 21 CFR, ISO 13485, and GAMP 5.
Experience in quality assurance, quality management systems, supplier quality management, and regulatory compliance.
Onsite role requires full-time presence in company facilities, office-based teams require at least 3 days per week on-site.
Experienced leader in quality assurance and supplier quality within disciplined, regulated environments.
Strong background in managing operational KPIs, risk management, CAPA methodologies, and continuous improvement initiatives.
Skilled in cross-functional collaboration and strategic operational planning involving product development, customer service, and sales teams.