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Full-time Quality Control Inspector - Medical Device - Irvine, CA

at Walk Vascular in California

Essential Duties and Responsibilities:

Responsible for the inspection and release of incoming, in-process, final and post sterile inspection of raw materials, components, finished products, assemblies and post sterile product, respectively. Also ensures the calibration of all equipment, tools and fixtures used to manufacture or make quality decisions. In addition, job functions include:
• Perform incoming, in-process and final inspections on raw materials, components, subassemblies, final assemblies, etc. and complete records according to procedure(s).
• Maintain the quarantine area(s) to ensure that all non-conforming, rejected material and material waiting for inspection are clearly labeled with status.
• Maintain, organize and ensure files are accurate and complete.
• Prioritize inspection based on manager, and demands of manufacturing and research & development.
• Support Quality Management in performance of quality reviews and audits.
• Ensure that items that require calibration are sent out for calibration in a timely fashion and that records and documentation are completed per the applicable procedure(s).
• Follows all safety guidelines.
• Maintain compliance with Quality System procedures and company policies
• Perform other related duties as assigned by supervisor


Education and/or Work Experience Requirements:

The candidate must be able to work in the U.S. The candidate must have a minimum of 2 years of continuous experience as a Quality Control inspector in the medical device industry.
• High school diploma or GED required
• Superb attention to detail
• Must have good oral and written communication skills
• Must have a knowledge of fundamental Metrology practices and principals
• Experience using a vision system, micrometers, calipers and other tools and gauges to perform inspection
• Ability to read and understand engineering drawings
• Must have visual acuity to distinguish colors and recognize non-conforming parts
• Must have basic proficiencies in Windows PC and Microsoft Office products
• Understanding of cGMP and FDA and ISO quality systems
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service


Physical Requirements:
• Ability to safely and successfully perform the essential job functions consistent with the FDA, ISO and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance
• Must be able to talk, listen and speak clearly on telephone

Reference : Quality Control Inspector - Medical Device - Irvine, CA jobs


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Published at 14-03-2018
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