Senior Supplier Quality Engineer - SFMD
Boston Scientific · Maple Grove, MN
- 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 Maple Grove, 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
Read from the posting. The full description is below.
How this role compares
Against 50 other live quality postings in Minnesota.
- Base pay
- Not listed in this posting
- Experience asked
- Typical (5+ years)
Typical $83k–$131k, from 30 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- Root cause 59%
- Six Sigma 43%
- ✓ Validation (IQ/OQ/PQ) 43%
- Lean 39%
- ✓ Supplier quality 39%
- FMEA 37%
✓ = this posting asks for it too. % = share of similar postings that mention it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Boston Scientific
We found 10 people at this company and state: 9 on the team, 1 leaders, plus 1 likely hiring manager. Engineers who joined in the last year or two reply the most. See them ↓
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
Write to Mackenzie → (free) - 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
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 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.
This plant: Boston Scientific in Maple Grove
3 other open roles at this site · 10 people we found on the quality team.
- Senior Quality Systems Engineer · Quality · Senior
- Design Quality Engineer III - Interventional Cardiology · Quality · Senior
- Sr. Supplier Quality Engineer - Metals · Quality · Senior
Full description from Boston ScientificAs posted on their careers site.ShowHide
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.
- ✓Ability to speak Spanish in a professional setting
- ✓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 ↓Show less ↑
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
Minimal
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