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Senior Supplier Quality Engineer - SFMD

Boston Scientific · Arden Hills, MN

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

The role in 30 seconds

A senior quality role at Boston Scientific (medical devices) in Arden Hills, MN.

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

Read from the posting. The full description is below.

It asks for 5+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

At a glance

Promotion path mentioned

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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

    Send a short, curious note

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  3. 3

    Turn a reply into a short call

    Questions worth asking about this team:

    • 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

    Bring proof to the interview

    One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.

About the role

About the role

The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Senior 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.

Your

qualifications

  • ✓BS degree in engineering or technical field with 5 years relevant experience.
  • ✓Experience in the medical device, automotive, aeronautical, semiconductor, or other regulated industry.
  • ✓Project management: the 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 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.
  • ✓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) strongly desired.

Minimum Salary: $ 85000

Maximum Salary: $ 161500

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.

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.

Show full description ↓

Recruiter: Spencer Gregory Hale

Senior Supplier Quality Engineer – SFMD

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.

New Product Development

  • •Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
  • •Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.

Quality System Champion

  • •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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