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Supplier Quality Engineer II - Direct Materials Acquisitions

Boston Scientific · Arden Hills, MN

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Level
Engineer
Team
Quality
Travel
25%
Degree
Required
Experience asked
2+ years
Industry
Medical devices
Posted
30+ days ago

The role in 30 seconds

An engineer-level quality role at Boston Scientific (medical devices) in Arden Hills, MN. In this role, you will support products within the acquisition space with a primary focus on components and applicable accessories.

They ask for
2+ years · degree required
Tools it names
CAPA, ISO 13485, Validation (IQ/OQ/PQ), Internal audits, Supplier quality
Day to day
about 25% travel

Read from the posting. The full description is below.

It asks for 2+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

At a glance

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How to get in at this plant

Five moves over a week or two. The first one takes ten minutes.

  1. 1

    Pick 2–3 people on the Quality team at Boston Scientific

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  2. 2

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  3. 3

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    • What does a normal week look like on your team?
    • Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
    • How much of the job is customer complaints versus prevention?
    • The posting says about 25% travel. Between which sites?
    • How did you land the job? What stood out in your interviews?
  4. 4

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  5. 5

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About the role

About the role

The Global Sourcing organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufactures components or finished devices for BSC distribution. The Supplier Quality Engineer will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier’s manufacturing processes. In this role, you will support products within the acquisition space with a primary focus on components and applicable accessories.

Your

Qualifications

  • ✓BS degree in engineering or technical field with minimum of 2 years of relevant experience.
  • ✓Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
  • ✓Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
  • ✓Experience in process validation, design controls, risk management, CAPA, SCAR.
  • ✓Ability to work independently; organized and self-driven.
  • ✓Articulate 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 25%.

Preferred Qualifications

  • ✓7+ years of medical device engineering experience preferred.
  • ✓Medical Device Industry experience
  • ✓Drug or animal tissue experience
  • ✓Problem Solving and Project Management experience
  • ✓Leadership experience on a materials or service commodity team.
  • ✓Lead auditor of quality systems experience (ISO 13485 or similar).
  • ✓ASQ certification (CQE, CBA, SSGB, SSBB) desired.

Minimum Salary: $ 71500

Maximum Salary: $ 135800

For MA positions : It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Show full description ↓

Recruiter: Spencer Gregory Hale

Supplier Quality Engineer – Direct Materials Acquisitions

Supplier/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.
  • •Manages sustaining quality issues, process change impacts, and design change implementations for suppliers within the Acquired Entity Quality system, the hybridized BSC-Acquired Entity Quality System, and in the BSC Quality System after products are successfully integrated.
  • •Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
  • •Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
  • •Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
  • •Investigates complaints and manages SCARs/NCEPs at component suppliers where the issue is manufacturing-related.
  • •Supports Supplier Change Impact Assessments for process changes at suppliers.
  • •Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
  • •Leads projects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process.

New Product Development

  • •Support manufacturing lines of acquired entity’s manufacturing line through integration of acquired company’s suppliers and products into BSC’s Quality System.
  • •Lead the execution of material controls quality deliverables and collaborate with cross-functional new product development teams to onboard suppliers.
  • •Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.

Quality System Champion

  • •Supports Material Controls external regulatory body audits requests as required.
  • •Leads or supports Material Controls internal audit efforts.
  • •Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
  • •Identifies and advises management on potential improvements to quality systems and processes in the company.
  • •Champions 100% compliance to company policies and SOP’s.

What we’re looking for in you

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