Senior QMS Process EngineerGForce Life Sciences • Saint Paul, Illinois, United States
Senior QMS Process Engineer
GForce Life Sciences
- Saint Paul, Illinois, United States
- Saint Paul, Illinois, United States
À propos
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
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Compétences linguistiques
- English
Avis aux utilisateurs
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