Supplier QA Eng - P4

Boston Scientific•,

6d•$63,800 - $121,200

About The Position

The Supplier QA Engineer drives improvement and corrective action in the quality of components sourced from outside suppliers. The role provides technical support in supplier selection, develops acceptance criteria for materials, and monitors supplier performance to address supplier corrective actions, manufacturing yield issues, and field failures. The position assesses potential suppliers' technical, quality, and manufacturing capabilities; supports the introduction and qualification of supplier components; and generates and maintains incoming inspection procedures. It also supports component specifications, testing and qualification reports, component selection, and design reviews from a quality and manufacturability perspective. The role investigates incoming material defects and supplier-related field failures, communicates issues to suppliers, and develops corrective action plans when needed. It may supervise inspectors.

Requirements

Bachelor of Science degree in engineering and at least 5 years of related experience, or an equivalent combination of education and work experience.
Experience in medical devices or another regulated industry.
Ability to influence cross-functional global teams spanning Quality, Operations, R&D, and Sourcing.
Experience in process validation, design controls, risk management, and CAPA.
Ability to work independently; organized and self-driven.
Articulate communication skills, including the ability to tailor information to the intended audience.
Problem-solving and project management experience.
Fully bilingual.
Experience managing supplier quality issues, including supplier nonconformance escalation and SCAR ownership.
Experience monitoring supplier performance and supporting continuous improvement activities.
Experience supporting component qualification and supplier process changes.

Nice To Haves

ASQ certification (CQE, CBA, SSGB, or SSBB).

Responsibilities

Assess potential new suppliers for technical, quality, and manufacturing capabilities.
Provide technical support for introducing components from new suppliers.
Generate and maintain incoming inspection procedures and train inspectors on them.
Develop or source inspection tools and equipment.
Assist in generating component specifications.
Generate test protocols, monitor testing, issue qualification test reports, and approve components for use in products.
Provide Design Engineering with input on new component technology and assist with component selection using quality and reliability analysis.
Analyze incoming material defects, determine dispositions, drive corrective action as necessary, and communicate issues to suppliers.
Review new design specifications and provide input on component quality and manufacturability.
Investigate field failures related to supplier materials and develop corrective action plans when necessary.
Monitor supplier performance and support continuous improvement activities.
Support component qualification and supplier process changes.
Manage supplier quality issues, including supplier nonconformance escalation and SCAR ownership.
May supervise inspectors.