Senior Supplier Quality Engineer

Boston Scientific•Spencer, IN

15h•$81,000 - $153,900

About The Position

The Senior Supplier Quality Engineer drives improvement and corrective action in the quality of direct components from external suppliers. The role provides technical support in supplier selection, develops acceptance criteria for materials, and monitors supplier performance to address corrective actions, manufacturing yield issues, and field failures. The engineer partners with suppliers and cross-functional teams to improve processes, reduce risk, and support the introduction and ongoing quality of components.

Requirements

Bachelor of Science in Engineering, Chemistry, or a similar technical field.
At least 5 years of relevant quality engineering experience in medical device manufacturing.
Experience with manufacturing process controls.
Demonstrated understanding of QSR and ISO standard requirements for Material/Purchasing Controls, Product Realization, Validation, and CAPA.

Nice To Haves

ASQ Certified Supplier Quality Professional or Certified Quality Engineer.
Subject matter expertise in problem solving.
Project leadership experience with packaging, sterilization validation, calibration, and analytical labs.
Understanding of Quality Agreements.
Ability to work independently; highly organized and self-driven.
Medical device industry expertise.

Responsibilities

Assess potential new suppliers for technical, quality, and manufacturing capabilities and support the introduction of components from new suppliers.
Generate and maintain incoming inspection procedures and train inspectors to follow them.
Analyze incoming material defects, determine dispositions, drive corrective action as needed, and communicate issues to suppliers.
Investigate field failures related to supplier materials and develop corrective action plans where necessary.
Influence cross-functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing.
Anticipate barriers to success and resource needs, identify alternatives for overcoming obstacles, and avoid near misses.
Mentor others in Supplier Quality Engineering competencies, including supplier compliance, change control, VIP, statistical aptitude, and application of quality tools.
Partner with suppliers on process improvements involving capability, risk reduction, and single-point failures.
Generate ideas to expand the impact of commodity teams across network customers and understand how industry and market changes affect the organization.
Build partnerships across the organization and make appropriate tradeoffs when evaluating the costs, benefits, and risks of cross-functional initiatives.
Act as a positive example and change agent for internal and external stakeholders.
Communicate proactively and effectively ahead of supplier, customer, or team needs; solicit input and involve others in decision-making.
Lead teams and projects, meet project milestones, create clear project plans, and develop contingency plans.
Make decisions with significant impact on the department and its customers, follow emerging trends, and educate peers in areas of expertise.