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Sr Supplier QA Engineer

Work mode:  Hybrid
Onsite Location(s): 

Arden Hills, MN, US, 55112

Recruiter: Spencer Gregory Hale

 

Senior Supplier Quality Engineer

 

About this role

The Supplier Quality Engineer will play a key part in leading performance improvement of suppliers and increasing the supplier’s capabilities to consistently meet Boston Scientific’s requirements. Additionally, the Supplier Quality Engineer will support global sourcing, manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects.

 

Your responsibilities will include:

  • Evaluates supplier caused manufacturing yield issues, incoming quality issues, and field failures and applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving the issues. Interacts with suppliers.
  • Leads root cause investigation and resolution with suppliers for non-conformances identified within the material lifecycle. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
  • Works in a category team develop and execute category strategy. Monitors supplier performance to drive continuous improvement. Identifies opportunities to improve component quality and supplier quality system connection. Develop proactive quality initiatives with suppliers.
  • Plans and leads supplier audits to assess compliance with regulatory and Boston Scientific requirements, including resolution of audit observation. Sustains incoming material acceptance and flow. Supports evaluation of proposed changes at suppliers. Influences quality in new material introduction and establish quality expectations with suppliers during material development.
  • 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.     
  • Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Participates in determining goals and objectives for projects. Leads projects within the department and represents a specialized field in larger project teams.

 

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

  • BS degree in engineering or related technical field with 6+ years of relevant experience.
  • Experience with quality systems and processes, and project management.
  • Ability to work independently; organized and self-driven.
  • Strong communicator, adept at packaging and appropriately scaling information to the intended audience.
  • Domestic and international travel up to 20%.

 

Preferred qualifications:

  • BS degree in electrical, mechanical, or biomedical engineering.
  • Experience with or working for medical device suppliers.
  • Demonstrated project management ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing.
  • Experience in design controls, production controls, risk management, and CAPA.
  • Lead auditor of quality systems, ISO13485 or similar.
  • ASQ certification (CQE, CBA, SSGB, SSBB).

 

 

Requisition ID: 581625

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.  


Nearest Major Market: Minneapolis

Job Segment: Biomedical Engineering, Compliance, Medical Device Engineer, QA, Quality Assurance, Engineering, Legal, Technology, Quality

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