Quality Assurance Engineer | 40HRS

Quality Assurance Engineer

Work Location: fremont, California

Job type: Full-Time

Posted: 02-28-2022

Salary: Negotiate

Email: job@40hrs.us

Job Description

Customer Quality & Factory Quality:
  • Managing all customer complaints, feedbacks and returns till complete closure.
  • Monitoring and improving customer complaints and customer returns rate.
  • Attending to all customer periodic audits, review meetings and visits.
  • Managing a team of inspectors in achieving the targets set by the management.
  • Supporting NPI activities for ODM and OEM products.
  • Preparing and updating products inspection checklist.
  • Ensuring all manufacturing processes conform to the approved quality system requirements.
  • Monitoring and improving the products quality performance to meet or exceed the quality targets set by the management or customer.
  • Conducting QIT meeting with QME team on a weekly basis. Monitoring and driving all open issues to complete closure.
  • Preparing weekly and monthly quality reports.
  • Participating in weekly MRR meeting to drive down inventory at MRB location.
  • Conducting quarterly ESD audit.
  • Attending to all certification audits and ensuring all identified findings and improvement items are closed as per agreed timeline.
  • Conducting products quality training to all inspectors and technicians.
2. Support Principal QMS Engineer in:
  • Maintaining and improving current Quality Management System.
  • Risk Assessment and Validation activities.
  • Product Safety Certification activities.

 

3. Product quality yield improvement activities. Approving all quality-related documents; e.g. manufacturing instructions, inspection checklist, inspection plans, etc.

4. Providing disposition for nonconforming materials/ products.
5. Determining the acceptance level of the product quality.
6. Purging and recalling nonconforming materials and finished goods.
7. Stopping production processes and deliveries in the event of any product nonconformance being detected during QA/ Customer inspections/ test.

Job Responsibilities

Please see JD...Thanks

Job Requirements

  • Minimum Degree in Electrical/ Electronic or Mechatronics Engineering. 
  • Diploma with at least 5 years of Quality Management experience will also be considered.
  • Minimum 5 years of hands-on experience in Quality Assurance activities. 
  • Experience in Medical Devices manufacturing processes
  • Expertise in leading or managing ISO14001, ISO9001 & ISO13485.
  • Good knowledge of Quality Systems and cGMP requirements within a regulated environment.
  • Good understanding of US FDA 21 CFR Part 820 and Part 11 regulatory requirements, QSIT/GHTF/IMDRF guidelines
  • Quality Tools (Acceptance sampling plan, SPC,MSA,FMEA,PPAP,APQP or 7 QC tools, etc)
  • Statistical analysis for problem solving.
  • Relevant IPC, MIL, Jedec, ANSI, etc. standards for electronic devices manufacturing
 

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