Senior Quality Engineer

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 140countries to develop highly specified solutions that enable customers to bring world-changing innovations to their end markets.

Position Title: Senior Quality Engineer

Location: Hudson, North Carolina - Hybrid (30% On-site) Travel Requirement:30-40%

Position Overview

The Senior Quality Engineer plays a critical role in ensuring product and process quality in a highly regulated manufacturing environment. This individual will work cross-functionally with Quality, Engineering, R&D, and Manufacturing teams to evaluate and improve production processes. The role also includes leading audits, supporting regulatory inspections, and mentoring junior team members to uphold quality standards. This is a hybrid role based in Hudson, NC, with approximately 30% on-site presence and 30-40% travel.

Primary Responsibilities

• Collaborate with cross-functional teams to develop and optimize manufacturing processes.
• Lead and support protocol development for IQ, OQ, and PQ validations.
• Conduct internal, supplier, client, and regulatory audits and inspections.
• Monitor critical process steps to ensure compliance with procedures and best practices.
• Present and manage complaints, risks, CAPAs, and process improvements.
• Act as Process Engineer during validations and troubleshooting efforts.
• Provide QA approvals and support for quality-related activities.
• Train and mentor team members on quality standards and strategies.
• Investigate and document deviations, non-conformances, and complaints.
• Promote a culture of quality across operations through influence and collaboration.

Minimum Requirements

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• 5-7 years of engineering experience, preferably in medical devices.
• Hands-on experience with IQ, OQ, and PQ validation protocols.
• Non-science degrees considered with 7+ years of relevant manufacturing experience.
• Fluent in English.
• Strong knowledge of quality systems and regulatory standards.
• Experience with cGMP (21 CFR 820) and cleanroom environments.
• Ability to lift up to 50 lbs and work in PPE/gowning environments.

Preferred Requirements

• 3+ years of experience in a people management role.
• Experience with continuous improvement and lean methodologies.
• Familiarity with ISO 13485, MDSAP, EU MDR, or single-use systems.
• Prior experience in medical device manufacturing.

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.