Quality engineer

Katalyst HealthCares and Life Sciences

• $80K — $110K *
Austin, TX 78745In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • 5+ years in Medical Device Quality & Compliance
  • Deep understanding of ISO 13485, 21 CFR 820, MDD/MDR
  • Hands-on experience in Quality Management Systems (QMS)
  • Experience with Complaint Management, Post Market Surveillance (PMS), and Non-Conformance (NC)
  • Strong expertise in Risk Management (ISO 14971) and FMEA.

Responsibilities

  • Lead design transfer and production support, ensuring FDA/ISO compliance
  • Own multiple subassemblies for a surgical robotics platform
  • Investigate Non-Conformances using root cause analysis and drive CAPA
  • Develop and maintain FMEAs and lead manufacturing issue resolutions
  • Identify and implement compliant solutions to engineering challenges
  • Support QMS processes and ensure regulatory compliance
  • Collaborate with cross-functional teams for quality outcomes
  • Interpret and apply medical device regulations to projects and processes
Full Job Description
Roles & Responsibilities :
  • Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness.
  • Own multiple subassemblies for a surgical robotics platform, ensuring design integrity, quality, and manufacturability.
  • Investigate Non-Conformances (Company) using root cause analysis and drive CAPA within the QMS framework.
  • Develop and maintain FMEAs, support risk mitigation, and lead manufacturing issue resolution and qualifications (IQ/OQ/PQ).
  • Identify and implement compliant, alternative solutions to engineering and production challenges while driving continuous improvement.
  • Support and maintain Quality Management System (QMS) processes in compliance with regulatory requirements.
  • Collaborate with cross-functional teams to deliver quality-compliant outcomes.
  • Interpret and apply medical device regulations and standards to projects and processes.
  • Support audits and regulatory inspections, ensuring timely closure of action items.

Education & Experience :
  • 5+ years of experience in Medical Device Quality & Compliance, with strong knowledge of ISO 13485, 21 CFR 820, MDD/MDR.
  • Hands-on experience in:
    • Quality Management Systems (QMS)
    • Complaint Management
    • Post Market Surveillance (PMS)
    • Non-Conformance (NC)
    • Corrective and Preventive Action (CAPA)
    • udits
  • Strong expertise in Risk Management (ISO 14971), including FMEA and data-driven quality decision-making.
* Ladders Estimates

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