As the largest pureplay adhesives company in the world, H.B. Fuller’s (NYSE: FUL) innovative, functional coatings, adhesives and sealants enhance the quality, safety and performance of products people use every day. Founded in 1887, with 2023 revenue of $3.5 billion, our mission to Connect What Matters is brought to life by more than 7,000 global team members who collaborate with customers across more than 30 market segments in over 140 countries to develop highly specified solutions that enable customers to bring world-changing innovations to their end markets.

H.B. Fuller Medical Adhesives Technologies is a recently formed business segment focused on growing adhesive solutions for the medical market. These solutions include finished medical devices (e.g. topical skin adhesives) as well as components for medical manufacturers (e.g. adhesives for medical device assembly). Find out more at www.hbfuller.com/medical.

Head of Quality Assurance, Medical Adhesive Technologies

Remote (US-based candidates only)

Travel: 50%-70%

Primary Responsibilities

• 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.

Minimum 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. Experience with ISO 22716 and MoCRA is a plus.

• 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.

Preferred Requirements

• Experience in finished medical devices and/or medical device components.

• Familiarity with the dynamics of both large organizations and midsized medical businesses.

Pay is based on several factors including but not limited to education, work experience, certifications, and geographic location.

Pay is based on several factors including but not limited to education, work experience, certifications, and geographic location.

In addition to your salary, H.B. Fuller offers employees a competitive total rewards package including comprehensive benefits, incentive and recognitions programs, health & wellness benefits, 401K contributions, paid time off and paid holidays. Eligibility may vary.

H.B. Fuller is an Equal Employment Opportunity employer and proud to have created a collaborative culture where employees around the world are seen, heard, and respected. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, or marital status or status as a protected veteran, or any other legally protected classification.

H.B. Fuller does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with H.B. Fuller, a written service agreement must be executed by Human Resources prior to submitting any information relating to a potential candidate. Without a signed service agreement, H.B. Fuller shall not be obligated for payment of any fee or compensation.