Quality Assurance and Document Control Clerk

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.

Primary Responsibilities

• Responsible for the overall coordination of controlled documentation within the company.

• Performs the Document Control function within the QMS system.

• Orders external standards and maintains tracking system.

• Assist in supporting external audits, coordinating activities in backroom and ensuring timely response to documentation requests for auditors.

• Supports user requests for documentation.

• Performs self-audits of Document Control and ensures that the current revision is available in a timely manner.

• Administers training system.

• Maintains quality records per applicable SOPs.

• Investigates and responds to corrective actions related to Document Control, Training and External Standards.

• Responsible for coordinating document change notices (DCNs), facilitates review, approval, and retention of Risk Management documents.

• Review and approve Quality Control testing and final Batch Records.

• Assure ongoing compliance with quality and industry regulatory requirements.

• Identify and organize training needs to meet quality standards.

• Develop, recommend, and monitor corrective and preventive actions for CAPA program.

• Investigate customer complaints and non-conformance issues.

• Other duties as assigned as deemed necessary by the supervisor.

Minimum Requirements

• Exercises judgement within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

• Experience working in a highly regulated industry. The Medical Device industry is subject to FDA registration, ISO 13485 certification, EC certification and various foreign country registrations.

• Strong verbal, written, organizational, time management and interpersonal skills.

• Strong computer skills, including working knowledge of MS Office and e-mail.

• Minimum of 2 to 5 years experience in the Medical Device industry preferred.

• Project management experience.

• Experience with electronic document control and training system preferred.

• Knowledge and experience with CE marking, labeling standards and practices is desirable.

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.