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Supplier quality engineer – medical device – bay area

Z&A Recruiting

This is a Full-time position in San Francisco, CA posted December 17, 2019.

This person is responsible for all aspects of Supplier Quality Engineering and Company’s Supplier Management Program, including supplier evaluations, supplier selection/approvals, supplier maintenance, and supplier improvement/development activities.

This person partners in selecting and managing the supply base and driving supplier improvement activities/initiatives Responsibilities Collaborate with suppliers to develop and implement standards and methods for processing, testing, validation and other activities targeting for quality and value improvements.

Conduct supplier evaluations, selection, maintenance, qualification/validation, and record-keeping activities in accordance with established requirements and procedures.

Support supplier development and continuous improvement activities targeted at achieving department objectives and meeting business needs/objectives.

Review and analyze production/manufacturing data to determine the primary factors affecting product quality, yield and cost and drive continuous improvement initiative with supplier as necessary.

Follow up on corrective and preventive actions related to supplier audit findings, nonconforming product/material and/or overall supplier performance to ensure effective resolutions and timely closure.

Assist in the development, approval, and maintenance of material specifications, supplier requirements/instructions, quality assurance procedures, supplier agreements, and supplier documentation Build and maintain effective cross-functional relationships with suppliers and internal departments such as Operations/Manufacturing, R&D/Engineering, Quality Control, and Regulatory Affairs.

Education / Experience Requirements Bachelor of Science in Engineering or Life Science discipline.

Minimum of 5 years overall experience as a Supplier Development or Supplier Quality Engineer.

Need at least 5 years’ experience in Quality Assurance; including at least 3 years’ experience in medical device manufacturing or pharmaceutical industries.

Demonstrated knowledge of applicable regulations and standards such as FDA, QSR, ISO, MDD, & IVDD.

Strong analytical skills, problem-solving techniques and statistical application experience.

Knowledge in the areas of Supplier Management, Design Controls, Process Validation, manufacturing practices, and statistical techniques.

Compensation: $130,000 $145,000 + 10% bonus and great benefits