Overview
Quality Engineering Technician Jobs in San Jose, California, USA at Shelby American, Inc.
Purpose
This position is responsible for providing Quality Engineering support in the design, development, manufacture, and post-market medical device activities.
Responsibilities
Assist in performing validation activities for processes, facilities, manufacturing, and test equipment in compliance with domestic and international regulations.
Support quality assurance activities, including, but not limited to: NCMRs and CAPAs.
Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause.
Assist in the resolution of quality issues related to non-conformance reports, Customer Complaints and CAPAs.
Provide Quality support to production and engineering.
Failure Analysis – Provide quality engineering support to analyze returned product.
Understand root cause investigation process and be able to initiate routine problem-solving investigations.
Assist in the timely investigation, resolution, and prevention of supplier quality issues which could disrupt business operations.
Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions.
Participate in the initiation, issuance, review, and approval of Supplier Corrective Action Reports (SCARs).
Collaborate with Operations on process improvement projects.
Investigate customer complaints and document investigation findings.
Perform inspection of incoming components, materials, and products.
Qualifications
4-year degree in an Engineering or Science discipline.
2 years minimum experience in a medical device environment.
Working knowledge of specifications, work instructions, standard operating procedures, regulations, and standards.
Ability to use word processing, spreadsheet programs, and email such as MS Office and Excel.
Salary & Benefits
The estimated hiring salary range for this position is $65,000 – 70,000. The actual salary will be based on a variety of job-related factors, including geography, skills, education, and experience. The range is a good faith estimate and may be modified in the future. This role is also eligible for a range of benefits including medical, dental, and 401K retirement plan.
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Title: Quality Engineering Technician
Company: Shelby American, Inc.
Location: San Jose, California, USA
Category: Quality Assurance – QA/QC, Engineering
