Regulatory Compliance Engineer

3 weeks ago


Dublin, Ohio, United States ICU Medical Full time

Job Description: We are seeking a Regulatory Compliance Engineer to join our team at ICU Medical. This is a unique opportunity for a quality-focused professional to ensure compliance with industry regulations and drive improvements in our manufacturing processes.

About the Role:

  • Ensure compliance with Quality System Regulations, such as QSR 21CFR820 and ISO-13485
  • Perform Gemba walks of the manufacturing areas to identify compliance risks and propose mitigations
  • Develop and implement corrective actions to resolve non-conforming reports (NCMRs) and CAPAs

Responsibilities:

  1. Owns or drives non-conforming reports (NCMRs/NCRs) and CAPAs from initiation to closure
  2. Ensures maintenance or updating of risk documents, such as PFMEAs and DFMEAs
  3. Supports qualification activities, including IQ, OQ, PQ, Test Method Validations, and Gage R&R/MSA

Requirements:

  • Bachelor's degree from an accredited College or University, preferably in Engineering or STEM areas
  • Previous regulated industry experience preferred
  • Experience in a clean room environment desirable

Estimated Salary Range: $95,000 - $130,000 per year, depending on experience and qualifications

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