Senior QMS Process Engineer

Remote • Posted 60+ days ago • Updated 10 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

Regulatory Compliance
Change Management
Medical Devices
QMS
ISO 13485
Application Lifecycle Management
Jama
Product Development
Quality Assurance
Research and Development
Organizational Skills
Management
Documentation
Technical Writing
Collaboration
Communication

Summary

Responsibilities:

Draft, update, and optimize QMS procedures to align with Code beamer 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.

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 Code beamer or similar ALM systems (e.g., Polariton, 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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 4cc263c7fd5d76dddadcba81822929b9
Posted 30+ days ago

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