Quality Engineer ManufacturingProduction
Quality Engineer ManufacturingProduction
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Salary Not Disclosed
1 Vacancy
Job Description
Position: Quality Engineer (Manufacturing/Production)
Duration: Long Term
Location: San Jose CA
Pay Rate: Open
Client: Confidential but will let you know once shortlisted
Job Description:
Background:
Our client is a large medical device and IVD manufacturer. They are currently in need of a Quality Engineer with a background in Quality Control Manufacturing and Production to investigate nonconforming materials coming from suppliers and determine the root cause to ultimately decide if the material is going to be sped returned or reworked.
Responsibilities:
The ideal candidate will come from a technical background and have experience working with manufacturing on the production floor. Day to day responsibilities will include:
- Identify document and track hardware defects and issues using appropriate tools and methodologies.
- Perform root cause analysis of hardware defects and propose effective solutions to prevent recurrence.
- Support the QA Team in the review and approval of ECO (Engineering Change Orders) (EDA) Engineering Deviation Authorization and EDA Extensions.
- Utilization of various quality tools techniques and methodologies including functional performance and reliability testing.
- In support of the Quality Management System (QMS) prepares issues inspects reviews and files all Quality Assurance documentation (batch records inspection records audits etc.) associated with production receiving shipping and testing operations where appropriate.
- Support with screening requested incoming shipments
- Review rejections and support the site (ME) Manufacturing Engineers in developing proper/effective dispositions for nonconforming material (Instruments Spares Parts).
- Support the Revision of (WI) Work Instructions (OP) Operating Procedures as required.
- Maintain internal quarantine parts/spares until the necessary inspection of those materials have been completed and approval given for transfer to the warehouse prior to manufacturing.
- Review and approve first article inspection reports to ensure they are in alignment with the latest specifications for custom products.
- Identify trends on a monthly basis of what is failing (processes parts etc.) and report those trends to management to promote improvements across the organization.
Required Experience:
- Medical Device 510 years
- Quality Engineering (Focused on Manufacturing / Production)
- Root Cause Analysis
- CAPA / NCR
- ISO 9001
- ISO 13485
Plus:
- SAP
Employment Type
Full Time
