Global Head of Quality Assurance - Medical Adhesive Technologies

December 3

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H.B. Fuller

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Packaging • Personal hygiene and nonwovens • General assembly • Building and construction • Paper converting

5001 - 10000 employees

Founded 1887

⚡ Energy

Description

• Develop, implement, and maintain an effective Quality Management System (QMS) in compliance with ISO 13485 and relevant standards. • Ensure compliance with FDA, ISO, EU MDR, and other regulations while guiding submissions and lifecycle management for medical adhesive products. • Lead internal and external audits, manage findings, and ensure timely corrective actions. • Oversee risk management efforts, including FMEA and fault tree analysis, from design through post-market surveillance. • Act as the primary liaison between customers and manufacturing plants to identify and resolve quality issues. • Establish and monitor key quality metrics (KPIs) to ensure product reliability, safety, and effectiveness. • Oversee product testing, validation, and compliance with design controls and process validations. • Develop and manage supplier quality programs, including audits, qualifications, and performance monitoring. • Collaborate with cross-functional teams to address quality issues, manage CAPAs, and drive continuous improvement. • Lead and mentor a high-performing quality team, fostering a culture of quality and compliance across the organization.

Requirements

• 10+ years of experience in quality assurance/quality control, with at least 5 years in a leadership role within the medical device industry. • In-depth knowledge of FDA regulations, ISO 13485, EU MDR, and other relevant regulatory standards. • Strong experience with quality management systems, risk management, CAPA processes, and supplier quality management. • Solid background in preparing, submitting, and maintaining regulatory submissions (e.g., 510(k), PMA, CE marking, and other market-specific registrations) for new adhesive products or medical devices, as well as for design changes and ongoing compliance. • Excellent communication and leadership skills, with a proven ability to lead cross-functional teams and influence at all levels of the organization. • Certification as a Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar is a plus.

Benefits

• comprehensive benefits • incentive and recognitions programs • health & wellness benefits • 401K contributions • paid time off • paid holidays