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Staff Engineer, Quality

Stryker · Waltham, MA

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Level
Senior
Team
Quality
Base pay
$107k–$179k
Travel
10%
Degree
Required
Experience asked
4+ years
Industry
Medical devices
Posted
29 days ago

The role in 30 seconds

A senior quality role at Stryker (medical devices) in Waltham, MA. Support manufacturing readiness, product transfer activities, and the transition from development to sustaining operations.

They ask for
4+ years · degree required
Tools it names
Lean, Six Sigma, Root cause, MSA / Gage R&R, CAPA, ISO 13485
Base pay
$107k–$179k
Day to day
about 10% travel

Read from the posting. The full description is below.

How this role compares

Against 56 other live quality postings in Massachusetts.

Base pay
About 26% above similar roles

Typical $97k–$130k, from 34 postings that list pay.

Experience asked
Less than usual (4+ vs 5+)

Similar roles usually ask 5+ years.

Skills these teams ask for most

  • ✓ Root cause 72%
  • ✓ FDA / GMP 53%
  • ✓ Validation (IQ/OQ/PQ) 53%
  • ✓ ISO 13485 47%
  • FMEA 44%
  • ✓ CAPA 44%

✓ = this posting asks for it too. % = share of similar postings that mention it.

It asks for 4+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

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. 1

    Pick 2–3 people on the Quality team at Stryker

    We found 2 people at this company and state: 2 on the team. 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 Patrick → (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?
    • The posting says about 10% travel. Between which sites?
    • 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: Stryker in Waltham

1 other open role at this site · 2 people we found on the quality team.

Full description from StrykerAs posted on their careers site.Show

What You Will Do

  • ◆Support manufacturing readiness, product transfer activities, and the transition from development to sustaining operations.
  • ◆Identify and implement process improvements that enhance product quality, manufacturing efficiency, inspection effectiveness, and compliance.
  • ◆Lead investigations of internal and supplier nonconformances, ensuring timely resolution and closure.
  • ◆Own Corrective and Preventive Actions (CAPAs), using root cause analysis to identify issues and implement sustainable solutions.
  • ◆Review and disposition nonconforming product through Material Review Board activities and containment actions.
  • ◆Partner with operations and cross-functional teams to resolve quality issues and maintain process compliance.
  • ◆Evaluate manufacturing and quality performance metrics, identify trends, and drive continuous improvement initiatives.
  • ◆Support manufacturing complaints, product field actions, and quality-related investigations.
  • ◆Review and approve change management activities, challenge effectiveness, and verify implementation of quality controls.
  • ◆Support process validation, equipment qualification, measurement system analysis, audits, and supplier quality performance activities.

Qualifications

  • ✓Minimum bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
  • ✓Minimum 4 years of experience in Quality Engineering, Quality Assurance, or a related quality-focused role supporting manufacturing operations within a regulated environment.
  • ✓Experience working within a regulated manufacturing environment.

Preferred Qualifications

  • ✓Experience in medical device manufacturing.
  • ✓Training or certification in Lean, Lean Six Sigma, or continuous improvement methodologies.
  • ✓Experience with process capability analysis, statistical sampling plans, and gauge repeatability and reproducibility (Gage R&R) studies.
  • ✓Working knowledge of ISO 13485, Good Manufacturing Practices (GMP), CAPA, risk management, audits, and statistical quality methods

US20 : $107,200 - $178,600 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Show full description ↓

Join Stryker’s Amplitude Vascular Systems (AVS) team in Waltham , Massachusetts as a Staff Quality Engineer . In this role, you will support manufacturing operations, supplier quality, and process performance across both existing and new products. Working closely with operations, engineering, suppliers, and cross-functional partners, you will help ensure products and manufacturing processes meet quality standards, regulatory requirements, and customer expectations.

This role offers a unique opportunity to support a newly integrated business preparing for commercial launch. As the site's primary Quality Engineer, you will play a key role in helping to establish quality metrics, drive process improvements, support manufacturing readiness activities, and enhance long-term quality and operational performance.

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