Document Control Specialist

ABOUT MECHANIX WEAR
 

Who We Are

Mechanix Wear develops protective gloves for industries including vehicle mechanics, police, military, trade professionals, and construction to name a few. Mechanix Wear is THE TOOL THAT FITS LIKE A GLOVE® In 1991, The Original® Glove was born. The brainchild of a legendary race mechanic that sparked a revolution for working hands. Championed by mechanics and pit crews at the 1991 Daytona 500, The Original® is the glove that started it all. For more information, visit www.mechanix.com.

What We Do

At Mechanix Wear, we are building a world where Safety is foundational, Performance is enhanced, and Trust in the brand is unshakable. We create and elevate protection beyond your expectations, through innovative design, advanced materials, and a relentless pursuit of excellence. We stand behind our core values including Thinking Big, Being a Problem Solver, Doing Things the Right Way, and TeaMWork.

JOB SUMMARY

The Document Control Specialist ensures the integrity, availability, and compliance of all controlled documents across our manufacturing operations. This role supports the Quality Management System (QMS) and regulatory requirements by maintaining accurate documentation, enabling efficient change control, and helping prepare for audits. The ideal candidate has strong attention to detail, experience with electronic document management systems (EDMS), and a working knowledge of quality and regulatory standards relevant to PPE and consumer products.

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ESSENTIAL RESPONSIBILITIES

• Manage the end-to-end document control process for all controlled documents (SOPs, work instructions, forms, specifications, validation/verification records, quality manuals, batch records, training records).
• Maintain and enforce version control, routing, approvals, metadata, and secure access within the EDMS (e.g., Master Control, Arena, or similar).
• Coordinate and track document changes through the change control process; ensure timely updates, archival, and distribution to affected stakeholders.
• Support internal and external audits by ensuring documents are current, traceable, and readily accessible; assist with evidence requests and corrective actions (CAPA) related to documentation.
• Ensure alignment of documents with applicable standards and regulatory requirements (ISO 9001, ISO 13485 if applicable, FDA QSR 21 CFR Part 820, REACH, RoHS, etc.).
• Maintain supplier-related documentation (quality agreements, certificates of conformity, material specifications) and ensure documentation reflects current supplier status.
• Manage training records and verify that employees have access to and completion of required procedures and work instructions.
• Assist with validation/verification documentation for processes and equipment; maintain document ownership and approval trails.
• Implement and monitor records retention schedules; oversee proper destruction of obsolete documents.
• Support label, packaging, and compliance documentation for PPE products as needed.
• Promote data integrity, accuracy, and security; enforce user access controls and audit trails.
• Collaborate with QA, Regulatory, Manufacturing, and Supply Chain to resolve document-related issues and drive process improvements. 
• Work closely with R&D, Product, Sourcing, Quality, Marketing and Manufacturing teams to collect and align product data, Testing, and Compliance 
• Support special projects during various product developments

MINIMUM QUALIFICATION

Bachelor’s degree in Quality Assurance, Engineering, Manufacturing, or a related field; or equivalent combination of education and experience.

EXPERIENCE

2–5+ years in document control, quality systems, or regulatory documentation in a manufacturing environment (PPE or consumer goods preferred).

• Proficiency with an electronic document management system (EDMS) and standard office software (MS Office 365).
• Familiarity with quality management principles and requirements (ISO 9001; ISO 13485 and FDA QSR knowledge a plus).
• Understanding of GMP/GLP concepts and regulatory compliance relevant to PPE/manufacturing.
• Ability to read and interpret technical drawings, specifications, and SOPs.
• Exceptional attention to detail and organizational skills.
• Strong written and verbal communication.
• Ability to manage multiple tasks and meet deadlines; collaborative mindset.

• Certifications: ASQ Certified Quality Auditor (CQA) or similar; Document Control Specialist certification.
• Experience with supplier documentation, validation/verification records, and audit preparation.
• Experience in a PPE, medical device, or consumer goods manufacturing environment.

ADDITIONAL INFORMATION

The Salary Range for this position at Mechanix Wear, LLC is $29.00 - $35.00 / hour (USD). Starting pay for the successful applicant depends on a variety of job-related factors, including but not limited to market demands, experience, training, skills, and education. The benefits available for this position include medical, dental, vision, 401(k) plan, life insurance coverage, wellness benefits, education reimbursement program, and Vacation time.

Mechanix Wear is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact the Mechanix Wear Human Resources department.