Quality Engineer ( Medical Device )

JOB TITLE
Quality Engineer ( heart valves )

LOCATION
Irvine, CA 92618

CLIENT
Medical Device

SUMMARY
The Quality Engineer will support the development of innovative new heart valves and delivery systems as well as the maintenance of current products and processes.  The Quality Engineer will ensure effective and comprehensive quality strategies for design development, verification and validation.  The individual will ensure the development and validation of appropriate test methods for product performance, and will conduct thorough investigations of quality issues and effective corrective and/or preventative action.  Specifically:

MANUFACTURING SUPPORT
- Perform/supervise product inspection and test
- Characterize finished product and component performance
- MRB activities
- Lend QE expertise to quality and cost improvement efforts, particularly improvements to measurement methods
- Specify statistically-based sampling plans
- Develop IQ, OQ, PQ protocols for manufacturing processes and test / inspection processes.  Execute protocols and write reports.
- Collect and organize data
- Work with component suppliers on quality issues
- Conduct process risk analysis
- Perform other Quality activities as needed

NEW PRODUCT DEVELOPMENT
- Participate in the development, review and approval of design verification and design validation protocols.  Execute protocols and write reports.
- Participate in the development of design requirements documents
- Conduct design risk analysis
- Lend Quality Engineering expertise to test methods development
- Perform other Quality activities as needed

REQUIREMENTS
• Bachelor of Science – Engineering
• Minimum 4 years Engineering experience in a medical device design / manufacturing environment
• Experience in testing and inspecting heart valves and components is desired
• Experience with nitinol is desired
• Statistical methods for quality are a plus
• Software validation is a plus
• ASQ, CQE, CRE or CSSBB certification is a plus
• Excellent verbal and written communication skills
• Proficiency with Microsoft office applications (Word, Excel)
• Hands-on individual with “can-do” attitude
• Ability to travel overseas (minimal)

TERMS / RATES
Direct hire
$75-90k DOE

QE
Q.E.