Quality Systems Engineer

23 hours ago

Jacksonville, Florida, United States Katalyst CRO Full time

Job Description

  • We are seeking a highly organized and adaptable professional to support our medical device development and quality operations. This role is ideal for a jack of all trades.
  • someone who enjoys creating order, connecting cross-functional efforts, and ensuring that studies, documentation, and processes run smoothly across multiple domains.
  • You will play a key role in structuring our studies and results, strengthening our Quality Management System (QMS), supporting validation activities, and driving overall operational excellence across R&D, Quality, and Regulatory functions.

Responsibilities:

  • Study Organization & Documentation Develop and maintain systems for organizing preclinical, clinical, and engineering study data and reports.
  • Track study progress, deliverables, and timelines; ensure results are documented and accessible.
  • Support coordination between internal teams and external partners.
  • Quality Management System (QMS) Support.
  • Assist in the maintenance and continuous improvement of the QMS in compliance with ISO 13485 and FDA 21 CFR Part 820.
  • Help manage document control, training records, and CAPA tracking.
  • Participate in internal audits and regulatory inspection readiness activities.
  • Validation & Compliance Activities.
  • Coordinate and document validation efforts (equipment, software, and process validations).
  • Support test plan creation, protocol execution tracking, and results compilation.
  • Work with technical teams to ensure traceability and compliance of all validation activities.
  • Operational Coordination.
  • Create and refine processes for project tracking, reporting, and information flow across teams.
  • Identify opportunities for efficiency and standardization.
  • Maintain dashboards or summaries of study and quality program status for management review.

Requirements:

  • Bachelor's degree in engineering, Life Sciences, Quality Management, or related field.
  • 3+ years of experience in medical device, biotech, or related regulated industry.
  • Broad understanding of quality systems, validation, and documentation processes (not necessarily deep expertise in one area).
  • Strong organizational and project management skills with keen attention to detail.
  • Excellent communication and collaboration abilities.
  • Comfortable working in a dynamic, cross-functional environment.
  • Familiarity with ISO 13485, FDA QSR, and risk management principles (ISO
  • Experience with QMS software, document control systems, or electronic validation tools.
  • Ability to translate complex technical information into clear, structured documentation.
  • A proactive mindset and natural inclination toward order, structure, and follow-through.

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