Senior QMS Process Engineer

GForce Life Sciences • Westminster, CO

85d • $72 - $86

About The Position

We are seeking two (2) Senior QMS Process Engineers to support a project focused on upgrading Codebeamer and implementing system enhancements to align with organizational and regulatory needs. These contract professionals will play a key role in authoring, revising, and optimizing Quality Management System (QMS) procedures to ensure compliance with global regulations while reflecting system and process improvements. We are looking for a senior level engineer who can effectively interpret process changes and translate them into clear, compliant procedural requirements.

Requirements

• Proven experience in the medical device industry, with strong knowledge of QMS documentation and procedures.
• Hands-on experience authoring and revising procedures compliant with ISO 13485, 21 CFR Part 820, and EU MDR.
• Familiarity with Codebeamer or similar ALM systems (e.g., Polarion, Jama, etc.).
• Strong understanding of regulatory and product development processes across Quality Assurance and R&D.
• Excellent technical writing, documentation, and organizational skills.
• Ability to work independently, manage multiple priorities, and deliver within tight project timelines.

Nice To Haves

• Prior experience supporting system upgrades or documentation alignment projects.
• Background in technical writing within regulated environments.
• Strong collaboration and communication skills, with the ability to partner across functions.

Responsibilities

• Draft, update, and optimize QMS procedures to align with Codebeamer upgrades, organizational standards, and regulatory requirements.
• Collaborate with cross-functional Quality and R&D teams to ensure procedures accurately reflect best practices and compliance expectations.
• Translate technical and regulatory requirements into clear, practical documentation for end users.
• Support change management processes, ensuring procedural updates are properly controlled and communicated.
• Ensure documentation is compliant with ISO 13485, 21 CFR Part 820, EU MDR, and internal quality system standards.
• Partner with stakeholders to validate that documentation aligns with both product development processes and regulatory needs.

Benefits

• Remote work arrangement
• Competitive hourly rate of $72-86/hr

What This Job Offers

• Career Level: Senior
• Number of Employees: 101-250 employees