Regulatory Compliance Engineer
3 weeks ago
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:
- Owns or drives non-conforming reports (NCMRs/NCRs) and CAPAs from initiation to closure
- Ensures maintenance or updating of risk documents, such as PFMEAs and DFMEAs
- 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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