Quality Systems Specialist

Salary Range: $66,870.26 To $92,280.96 Annually

Team:
Quality

As a Pro Med employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

Pro Med was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

Working as one to help many.

The Quality Systems Specialist is responsible for the day-to-day administration, maintenance, and continuous improvement of document control within the Quality Management System (QMS), ensuring QMS components are accurate, current, properly revised, approved, accessible, and archived in compliance with regulatory requirements for the pharmaceutical and medical device industries. This position exercises independent quality judgment on decisions affecting Pro Med’s manufacturing activities. The Quality Systems Specialist supports Pro Med’s mission and values by applying and reinforcing the company’s brand, philosophy, systems, policies, and procedures are consistently applied and upheld in all aspects of their work.

You'll ensure Pro Med's Quality Management System remains accurate, current, and audit-ready by maintaining tight control over the lifecycle of every controlled document — from creation through revision, approval, distribution, and archiving. Your work will keep the organization compliant with ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11, while driving continuous improvements that strengthen the QMS and support manufacturing operations.

• Administer the day-to-day operations of the document control system, including issuance, revision, approval routing, and archiving of controlled documents (SOPs, work instructions, forms, specifications, and quality records)
• Maintain document master lists and revision histories to ensure all controlled documents reflect the current approved version
• Manage physical and/or hybrid document distribution, including retrieval and destruction of obsolete documents from points of use
• Assign and maintain document numbering schemes, version control conventions, and document retention schedules consistent with site SOPs and regulatory requirements
• Ensure document templates are standardized, current, and compliant with applicable regulatory and quality standards
• Manage electronic and physical document repositories

• Process document change requests, track change history, and support change impact assessments in collaboration with subject matter experts (SMEs)
• Oversee the creation, review, approval, and distribution of controlled documents — including SOPs, policies, forms, and work instructions — in accordance with ALCOA principles
• Support the periodic review process for controlled documents, notifying document owners of upcoming review dates and coordinating timely completion
• Coordinate training assignments for new and revised documents, ensuring training records are completed and filed in a timely manner

• Maintain documentation files in compliance with ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11
• Input data to create and revise material and method masters in the ERP system

• Make independent quality decisions and notify management of actions taken
• Identify, propose, and…