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Quality Assurance/Regulatory Affairs Engineer

City of Industry, CA 91748

Posted: 10/03/2022 Employment Type: Direct Placement Category: Quality Job Number: 95336

Job Description


Summary

 

Responsible for the analysis of product, process, equipment and method issues at designated stages of product development and manufacturing. Lead and support action to prevent and reduce all costs associated with poor quality. Work to maximize product conformance to specified requirements while ensuring best possible manufacturability.

 

Essential Job Responsibilities
  • Provide quality support for gas/liquid analyzer and medical device portfolio products.
  • Ensure that all applicable regulatory standards and directives are applied and managed, including ISO 9001 and 13485, NEC 500/505, FM, UL, CSA, ATEX/IECEx, US FDA, MDD/MDR and other in-country regulations. 
  • Continuously improve the Quality Management System.
  • Support all third-party inspections and audits, as well as supplier audits.
  • Responsible for in-process and final quality inspections, training, and receiving inspection.
  • Support Management Review, Post Market Surveillance, and Complaint Reporting activities.
  • Interpret engineering drawings, specifications, purchase orders, work orders, etc., to determine quality status.
  • Document results of inspections. Identify and clearly communicate nonconformance’s to Management in a timely manner.
  • Report to Manager of Quality.
  • Occasional domestic travel may be required.

 

Qualifications
  • 4-year degree in related technical discipline.
  • Minimum of 3 years of Quality Assurance experience related to analytical instrumentation and/or medical device products.
  • A strong working knowledge of ISO 9001 and/or ISO 13485 is required; knowledge of MDD/MDR is desired.
  • Must demonstrate effective written and verbal communication skills.
  • Must be able to work well under pressure and meet tight deadlines with minimal supervision.
  • Responsiveness and attention to detail are priorities.
  • Certified Lead Auditor for ISO 9001 and/or 13485, preferred

P-OCE-3
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