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Supplier QA Engineer III

1 month ago

Maple Grove, United States Boston Scientific Full time

Recruiter: Spencer Gregory Hale

Supplier Quality Engineer III

About this role
The Supplier Quality Engineer III will play a key part in the Integration team for Peripheral Interventions and Intervention Cardiology acquisitions. Review the supply base, identify potential issues and work to resolve current quality system or supplier gaps. Develop quality strategies and provide input and influence to maintain compliance and integrate acquired entities and products into Boston Scientific Quality System as needed. Drive continuous improvement to the acquisition process.

Your responsibilities will include:

Supports integration activities of new sites, focusing on onboarding of new suppliers as a lead auditor in the quality management assessment, setting up incoming inspection documentation, and hybridizing procedures and knowledge sharing documents. Works cross-functionally in identifying and resolving technical issues. Maintains and enhances cross-functional team relationships within the divisions, plants, distribution centers, across the entire BSC network. Monitors, evaluates, and provides summary reports on project progress and results. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents. Champions 100% compliance to company policies and SOP’s. Assists in generating materials specifications and working with the supplier engineering function in qualifying material per BSC Quality Management System requirements. Provides guidance regarding quality integration strategies and approaches to new acquisitions relating to product distribution and quality systems (i.e. CAPA, Post Market, distribution controls)

Sustaining Engineering:

Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation. Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers. Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.

What we're looking for in you:
Minimum qualifications:

BS degree in engineering or related technical field with minimum of 2-3 years of relevant experience. Experience in medical device. Project management: 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. Strong communicator; adept at packaging and appropriately scaling information to the intended audience. Ability to rapidly learn and use new software applications (e.g., PLM, ERP). Domestic and international travel up to 20%.

Preferred qualifications:

Experience with quality systems and processes, and project management. Experience with medical device suppliers Experience as lead auditor of quality systems (ISO13485 or similar) ASQ certification (CQE, CBA, SSGB, SSBB).

Requisition ID:  588069

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.