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Senior Quality Engineer - Cardiac Diagnostics (CDx)

Boston Scientific · Arden Hills, MN

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Level
Senior
Team
Quality
Degree
Required
Experience asked
2+ 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. Advise, review and approve process validation and verification activities that support corrective actions.

They ask for
2+ years · degree required
Tools it names
Six Sigma, Root cause, FMEA, CAPA, ISO 13485, Validation (IQ/OQ/PQ)

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

Typical $83k–$131k, from 30 postings that list pay.

Experience asked
Less than usual (2+ vs 5+)

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.

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

Promotion path mentioned

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. 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. 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. 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?
    • How did you land the job? What stood out in your interviews?
  4. 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. 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 Arden Hills

12 other open roles at this site · 10 people we found on the quality team.

All 13 roles at Boston Scientific →
Full description from Boston ScientificAs posted on their careers site.Show

Required Qualifications

  • ✓Bachelor’s degree in engineering or related discipline
  • ✓5 or more years of relevant quality engineering experience (3 or years with a relevant master's degree).
  • ✓Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards.
  • ✓CAPA experience including leading root cause investigations, implementation of corrective actions and verification of effectiveness
  • ✓Familiar with medical device risk management activities and their connection to organizational processes
  • ✓Familiar with quality tools and problem-solving techniques
  • ✓Experience in Medical Device industry

Preferred qualifications

  • ✓Prior interactions with the following disciplines: software and hardware development, manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineering
  • ✓Experience working with MS Office applications and PLM (Windchill)
  • ✓2+ years’ experience in Validation, Statistical sampling and/or Root Cause Investigation
  • ✓Familiar with QMS documentation including but not limited to DHF, DMR, DHR, SOPs, WIs, FMEAs and other Quality records
  • ✓Problem Solving Certification (CQE, Six Sigma, etc.)
  • ✓Demonstrated program/project management skills
  • ✓Critical thinker and active listener with good time management skills
  • ✓Self-starter with the ability to quickly learn about new processes
  • ✓Excellent analytical and communication skills (written and oral)

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.

Show full description ↓

Recruiter: Spencer Gregory Hale

Senior Quality Engineer - Boston Scientific Cardiac Diagnostics (CDx)

About this role

We are seeking a Senior Quality Engineer to provide critical quality engineering support to the Boston Scientific Cardiac Diagnostics’ business ensuring the highest quality results to improve the business’ products, services, and processes. The role will lead quality initiatives centered on continuous improvement and organizational compliance while partnering closely with cross-functional product development, supplier, and production teams to lead the organization’s Corrective and Preventive Actions (CAPA) process.

In a fast-paced, high growth and dynamic environment, this position will be key in supporting the engineering, production and commercial teams achieve their business unit goals. The ideal candidate will be comfortable interfacing with multi-disciplined teams at all levels to provide quality leadership, facilitate complex problem solving, and drive effective solutions for impactful and highly visibility issues.

Your

will include

  • •Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • •Act as an effective leader and team member in supporting quality disciplines, decisions, and practices.
  • •With input from organizational stake holders organize, schedule, and conduct investigational and problem resolution meetings with cross-functional team members to coordinate, contribute to and document NCEP/CAPA processes including determinations, activity tracking, and record closures.
  • •Evaluate the adequacy and compliance of systems and practices against regulations and company documentation.
  • •Participate in team decision making and display team problem solving/communication skills.
  • •Proactively investigate, identify, and implement best-in-class Quality Engineering practices.
  • •Collaborate with technicians and engineers in dispositioning non-conforming material, assisting in identification of manufacturing process defects, identification of primary root causes, and understanding corrective and preventative actions. May be responsible for working with process owners, suppliers, and other internal groups
  • •Advise, review and approve process validation and verification activities that support corrective actions.
  • •Collect and analyze process defect data for product/process improvement efforts (e.g., nonconforming product, failure analysis, customer complaints, etc.)
  • •Support NCEP/CAPA activities as Subject Mater Expert, mentor, and trainer.
  • •Support regulatory submissions to notified bodies.
  • •Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

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