Senior QMS Process Engineer

GForce Life Sciences; United States; Remote; USD 82,656 - 89,544; Full time

Job summary

A leading life sciences company is looking for two Senior QMS Process Engineers to enhance their Quality Management System. The role involves authoring and optimizing procedures and ensuring compliance with regulations. Ideal candidates have experience in the medical device industry and are familiar with ISO standards and Codebeamer. This is a remote, 3-month contract position requiring 40 hours per week.

Qualifications

• Proven experience in the medical device industry.
• Strong knowledge of QMS documentation and procedures.
• Ability to work independently and manage multiple priorities.

Responsibilities

• Draft, update, and optimize QMS procedures.
• Collaborate with cross-functional teams for compliance.
• Translate regulatory requirements into clear documentation.

Skills

QMS documentation

ISO 13485

regulatory knowledge

technical writing

project management

Tools

Codebeamer

Polarion

Jama

Job description

Base pay range

$60.00/hr - $65.00/hr

Overview

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 author, revise, and optimize Quality Management System (QMS) procedures to ensure compliance with global regulations while reflecting system and process improvements. They will interpret process changes and translate them into clear, compliant procedural requirements.

Key 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.
• 3‑month contract, 40 hrs/week
• Remote