Senior Quality Systems Engineer 693P

Job Requisition # 693P

Thoratec Corporation is a leading manufacturer of circulatory support products for use by patients with congestive heart failure. We sell Ventricular Assist Devices, or VAD’s, to virtually every leading heart transplant center in the world, marketing three out of the four VAD’s approved by the U.S. Food and Drug Administration. We are also a leading provider of point-of-care blood diagnostic test systems.

We are currently seeking a Senior Quality Systems Engineer to join our team of Quality Engineers in our Corporate Headquarters located in Pleasanton, California. The individual will provide Quality Engineering support to assigned projects, programs or areas of new product development to ensure that the product is built in accordance with customer, corporate and regulatory requirements. This is a senior level technical position.

DUTIES/RESPONSIBILITIES:
Develops, implements and maintains cost-effective Quality System procedures consistent with corporate, government and international regulations. Leads quality improvement projects that benefit the inspection, testing, assembly, or development of products. Keeps abreast of changes to domestic and international regulations, standards, and guidance documents. Applies knowledge of FDA Quality Systems Regulations and International quality system standards in carrying out responsibilities. Participates as a cross-functional team member in new product development team activities, representing the interests and concerns of the quality assurance/quality engineering function. In new product development, develops and implements effective inspection, measurement and test equipment to verify compliance of product with specifications. Specifies, plans and purchases such equipment when necessary. Assures calibration/maintenance, training, proper use and handling of equipment by department personnel. Conducts failure investigation to analyze internal system or process failures and implement preventive and corrective action, using various statistical and non-statistical problem-solving tools as part of analysis. Assists in the training of Quality Assurance, Development, and/or Production employees in Quality System related procedures or improvement programs. Develops and maintains risk management files include the generation or participation in Failure Mode Effects Analysis or Fault Tree Analysis, determination of risk hazards, and construction of risk reports. Implements and maintains systems to report and improve quality. Minimum travel.
REQUIREMENTS
BS degree in Engineering discipline; Electrical Engineering degree highly preferred. Minimum of 5 years experience in quality assurance / quality systems. Medical device industry and with GMP/QSR’s preferred. Solid working knowledge of the FDA Quality Systems Regulations and international quality system standards is required. Proficiency in the use of personal computers and computer database software, including Microsoft Office applications (Access, Excel, Word and PowerPoint). Visio and Project knowledge desirable. ASQ certification (CQE/CQA/CRE) strongly desired. Must have excellent communication skills (written & verbal), organization skills, and a team attitude. Demonstrated leadership skills that include project planning, leading team meetings, and monitoring and reporting project progress to senior management. Ability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.

Note: It is important in include Job # 693P when applying for this position.

Thoratec offers an excellent benefits package with opportunities for advancement. Email your resume and salary requirement to [Click here for email]. For more information on Thoratec and our products, please refer to our website at www.thoratec.com. EOE M/F/D/V.