Supplier Quality Engineer - Medical Devices 678P

Job Requisition # 678P

 

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 have an excellent opportunity for a Supplier Quality Engineer in our Corporate Headquarters located in Pleasanton, California.  This individual will be responsible for conducting key objectives of the supplier quality audit program. He/she will help establish, implement, and maintain a quality audit program that verifies Thoratec supplier quality management systems are in compliance with 21 CFR Part 820, Good Manufacturing Practices, and international standards and requirements, such as ISO 13485, Medical Device Directives, Active Implantable Medical Device Directives, and Canadian Medical Device Regulations. Oversees various supplier quality management activities. The successful candidate must be able to support the supplier quality system to achieve the highest levels of efficiency, quality, and cost savings.

DUTIES/RESPONSIBILITIES
Works together with Purchasing & Engineering to select and approve suppliers. Develops a supplier audit schedule and ensures audits are conducted on a scheduled basis. Prepares audit reports based on audit findings. Follows up on corrective actions related to audit findings, nonconforming product, or overall supplier performance to ensure effective resolution and timely closure. Maintains master files of supplier audits and correspondence with suppliers per record retention requirements. Works with Purchasing to track ongoing supplier quality performance and work with suppliers on quality issues. Participates in activities required to qualify suppliers and maintain for various levels of approval, such as preferred, dock to stock, and certified suppliers. Interfaces with receiving inspection personnel. Works with Purchasing, Engineering, Manufacturing and Quality Assurance on supplier issues to assure timely acceptance of purchased product. Assists in the development, approval, and maintenance of Thoratec material specifications, vendor instructions, quality assurance procedures, as well as supplier documents such as Quality Control Plans. Assists in the development and qualification of Thoratec and vendor located inspection, measurement and test equipment. Collects and analyzes quality information from various quality systems and develops reports as needed for senior management review. Provides recommendations based on trends. Conducts or assists in systems/process/product failure mode analysis and initiation of preventive action as it applies to purchased product. Develops and maintains specifications & SOP's in area of responsibility. Understands and is able to review quality records to verify information is correct and complete and that specifications have been met. Identifies and drives continuous quality improvement in area of responsibility. Ability to travel approximately 15? 40% of time for supplier visits.

EDUCATION AND EXPERIENCE
BS/BA degree or equivalent, preferably in a technical field such as Science or Engineering. Minimum of 4 years experience in quality assurance / quality systems, 2 of which were involved with supplier quality. Minimum of 2 years experience in the medical device industry. Must be proficient in use of personal computer and business/technical software (Word, Access, Excel, Power Point). Formal training and experience in auditing required. Must possess thorough knowledge of the Quality Systems Regulations and international quality systems and medical device standards.

NOTE: It is very important that you include the above requisition number when applying.


Thoratec offers an excellent benefits package with opportunities for advancement. Please email your resume and salary requirement to HRJobsCA2@thoratec.com EOE M/F/V/D