Incredible Bay Area based Medical Device Company is adding to the team. This well-established Company is known for its, team atmosphere, internal promotion track record, and work life balance – Incredible time in the Company evolution – double digit growth! This is a great role on a Supplier Quality team for Medical device!

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.
• 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 - Supplier Quality

• 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.

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

Supplier Quality

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