Quality Engineer-Medical Device/Equipment Validation/Product Quality
Global leader in the healthcare/medical product manufacturing industry is currently looking a Quality Engineer in Irvine CA. This is a contract position expected to last 6 months, could be longer based on performance. Currently we are only looking for local candidates. Great Contractor Benefits! Apply Now!
Responsibilities:
-> Prepares, executes, and finalizes requirements and design specifications and protocols (IQ OQ, PQ, and SV) for validating new equipment and modifications to existing manufacturing equipment, laboratory equipment, critical systems, and manufacturing processes
-> Manages/performs/assists in the validation qualification of new products and processes related to the manufacturing facility
-> Performs final review of development/feasibility studies, protocols, and final reports to ensure conformance to FDA regulations
-> Investigates exceptions/deviations to determine the impact on product quality, root cause investigation, and impact on validation outcome
-> Participates in internal and external Audit related activities and implements corrective/ preventive actions
-> Maintain working knowledge of the CAPA procedures and participate in CAPA related activities including CAPA ownership as necessary
Requirements:
-> Bachelor's Degree (B.S.) from four year accredited college or university
-> 3-6 years related experience in pharmaceutical, medical device or other FDA regulated industry
-> Working knowledge of 21CFR820 (quality systems regulation/good manufacturing practices for medical devices), 21CFR11, software validation, and ISO 13485 standards
-> Experience in automation and PLC programming preferred
-> Strong working knowledge of FDA, ISO, and EU Regulations including 21CFR Part 820 Quality System Regulations, 21 CFR Parts 210 & 211, 21 CFR Part 11, EU Annex 15 & 18, FDA Guidance for Software Validation, and ISPE GAMP Guidance
Benefits:
-> Paid Vacation
-> 401K
-> Health Insurance, and more...
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