Ecocareers ยท 3 months ago
Senior QMS Process Engineer
United States
Full-time
Remote
Senior LevelConfidential company is seeking a Senior QMS Process Engineer. The role involves drafting and optimizing QMS procedures while ensuring compliance with regulatory standards and collaborating with cross-functional teams.
Staffing & Recruiting
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
Qualification
Required
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
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
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase