Manufacturing Quality Expert
7 days ago
Job Summary: We are seeking a highly skilled Manufacturing Quality Expert to join our team at ICU Medical. This is a rewarding opportunity for a quality-focused professional to drive improvements in our manufacturing processes and ensure compliance with industry regulations.
About the Role:
- Ensure compliance with Quality System Regulations, such as QSR 21CFR820 and ISO-13485
- Perform root cause investigations using problem-solving tools, such as 5WHYs and Ishikawa
- Develop and implement corrective actions to resolve non-conforming reports (NCMRs) and CAPAs
- Collaborate with cross-functional teams to drive systemic improvements in manufacturing operations and quality systems
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
- Performs statistical analysis of various types of manufacturing data using tools like Minitab
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: $80,000 - $110,000 per year, depending on experience and qualifications
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