Katalyst CRO ยท 3 months ago
Senior QMS Process Engineer
United States
Full-time
Remote
Senior LevelKatalyst CRO is a company focused on quality management systems in the medical device industry. They are seeking a Senior QMS Process Engineer to draft and optimize QMS procedures, ensuring compliance with regulatory standards and collaborating with cross-functional teams.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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