Quality Assurance Engineer - Medical Device

JOB TITLE
Quality Assuance Engineer

 

CLIENT
Medical Device firm...primarily manufactures catheters

 

RESPONSIBILITIES
Responsible for Quality Engineering support of client product line at the direction of the Director, Quality Assurance.

Key member of the product development team.  The incumbent is  responsible for coordinating validation and reliability testing. 

Responsible for managing equipment maintenance and calibration activities. 

Will perform and report results of testing of returned product. 

Perform testing of in-process sub-assemblies and assist in system development testing.  Will also develop and design fixtures for hardware testing. 

Manage the IRR/MRR level of the Corrective Action System and support the Director of QA/CA/RA in the management of the CAT level.

The incumbent has a total familiarity with the Device GMP Regulations and client?s Quality Systems requirements and assures that these are followed.

Provide general Quality Engineering support that includes, but is not limited to:
?Support of audit activities both internal and external
?Support of supplier management activities.
?Training of staff in procedural and regulatory matters

 

QUALIFICATIONS / REQUIREMENTS
Must have a Degree in Engineering and at least 1 ? 2 years of laboratory experience in engineering, chemistry, biology or applied fields. 
Must be self-motivated & multi-task oriented. 
Must also have excellent technical, written and verbal skills and be highly organized. 

 

POSITIONS SUPERVISED
Technicians and Inspectors at the request of the Director RA/QA/CA.

 

LOCATION
Irvine, CA

 

TERMS / RATES
$60-90k annually
con-dir, or direct hire