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Senior QMS Process Engineer
Senior QMS Process EngineerKatalyst HealthCares & Life Sciences • Remote, NJ
Senior QMS Process Engineer

Senior QMS Process Engineer

Katalyst HealthCares & Life Sciences • Remote, NJ
[job_card.30_days_ago]
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  • [job_card.full_time]
  • [filters.remote]
[job_card.job_description]

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 , CFR Part , 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 , CFR Part , and EU MDR.
  • Familiarity with Code beamer or similar ALM systems (, 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.


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Senior QMS Process Engineer • Remote, NJ

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