Quality Engineer

San Rafael  ‐ Onsite
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Description

GENERAL DESCRIPTION:

This position, reporting to the Director of QA, has responsibilities in the following areas:Verification and Validation, Statistical Process Control, Product Control, including protocols and procedures, Complaint Analysis, and participates in Material Review Board. Administer CAPA Program, perform audits, disposition non-conforming product and create supporting documentation. The position will work with both R&D and Production to support the development, transfer, maintenance, and improvement of production processes for products in accordance with the company's Quality Systems and customer contracts. This position has direct responsibility for improving process control, product quality and reduction of production costs.
Process Development: Support efforts for developing or improving process capabilities, improving product manufacturability, and reducing scrap and production costs. Create production fixturing IQs and OQs. Create and review process and IQC inspection documentation. Create and validate standard test methods. Interface with Development Engineering in the transfer and qualification of products and processes. Develop and implement QC processes compatible with continuous flow manufacturing processes. Develop, implement and monitor Statistical Process Control charts.
Compliance: Perform engineering testing and validation. Analyze product complaints and create complaint analysis reports. Create associated documentation in accordance with domestic and international regulatory requirements. Utilize statistical methods to analyze test data and present data in investigative reports. Perform cross-functional departmental audits and Supplier Quality audits.

Requirements:

* BS in Engineering or related discipline or equivalent experience

* Min 4 years medical device (preferred) or biotech experience

* FDA QSR and ISO 13485 compliance experience required

* Strong understanding of Product Development Processes required

* Validations experience required

* Solidworking knowledge of statistics required

* Basic understanding of statistical process control (SPC) required

* Strong understanding of metrology preferred

* Test method validation experience preferred

* Lean Manufacturing experience preferred

* Project Management/Planning experience preferred

* Excellent communications skills (both written and verbal) required

* Strong basic computer skills (MS Word, Excel) required

* Familiarity with SolidWorks, statistical software desired

* ASQC QE certification preferred

* 6-sigma training desired

* Ability to work independently or in team setting

To find out more about Real please visit www.realstaffing.com
Start date
10/2013
From
Real Staffing
Published at
11.10.2013
Project ID:
611436
Contract type
Freelance
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