Senior Engineer, Quality Assurance

Posted 8 Days Ago
Be an Early Applicant
Portage, MI, USA
In-Office
70K-168K Annually
Senior level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
Lead critical quality investigations for emergency-care medical devices, including field action assessments, root cause analysis, post-market health risk evaluations, containment recommendations, and CAPA records. Coordinate reviews across R&D, manufacturing, regulatory, quality, marketing, service, and suppliers. Support internal and external audits while maintaining compliance with quality systems, risk management, and post-market requirements.
Summary Generated by Built In
Work Flexibility: Hybrid

Senior Quality Assurance Engineer

Redmond, WA or Portage, MI


Join a team where your expertise directly impacts patient safety and product performance. As a Senior Quality Assurance Engineer, you’ll lead Emergency Care critical investigations and drive improvements that shape the future of medical technology. This is a high-impact role for someone passionate about solving complex problems and ensuring quality excellence across the product lifecycle.

Work Flexibility:
Hybrid: Candidates must reside within a commutable distance to Redmond, WA or Portage, MI, and be able to work onsite several times per week.


What you will do

  • Lead product field action assessments from initiation through review and approval, ensuring complete, accurate, and timely documentation.
  • Investigate complex product quality issues using structured problem-solving, root cause analysis, and statistical evaluation methods.
  • Perform post-market health risk assessments and health hazard evaluations to assess potential product and patient safety risks.
  • Develop containment recommendations and corrective actions based on investigation findings, risk assessments, and quality data.
  • Author and manage nonconformance and corrective and preventive action records, including defined deliverables, action owners, timelines, and supporting documentation.
  • Coordinate investigation and corrective action reviews with Research & Development, Manufacturing, Regulatory, Quality, Marketing, Service, and supplier teams.
  • Represent Quality Assurance processes during internal and external audits and maintain compliance with applicable quality system, risk management, and post-market requirements.

 

What you will need

Required Qualifications

  • Bachelor’s degree in science, engineering, or a related discipline.
  • Minimum 2 years of experience in quality assurance or customer quality.
  • Experience working in a regulated industry, such as medical devices or aerospace.
  • Experience conducting post-market quality assessments.

Preferred Qualifications

  • Master’s degree in science, engineering, or related discipline.
  • Experience conducting product field actions.
  • Experience working with ISO 14971, ISO 13485, 21 CFR Part 820, and European Union Medical Device Regulation requirements.
  • Six Sigma Green Belt certification or experience with formal investigative techniques.

  


United States of America Pay Ranges:

  • Puerto Rico: $69,500 - $110,900 USD Annual
  • USN: $77,700 - $129,500 USD Annual
  • US5: $81,600 - $136,000 USD Annual
  • US10: $85,500 - $142,500 USD Annual
  • US15: $89,400 - $148,900 USD Annual
  • US20: $93,200 - $155,400 USD Annual
  • US30: $101,000 - $168,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.

  


Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

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.

Skills Required

  • Bachelor's degree in science, engineering, or a related discipline
  • At least 2 years of experience in quality assurance or customer quality
  • Experience working in a regulated industry, such as medical devices or aerospace
  • Experience conducting post-market quality assessments
  • Master's degree in science, engineering, or a related discipline
  • Experience conducting product field actions
  • Experience with ISO 14971, ISO 13485, 21 CFR Part 820, and European Union Medical Device Regulation requirements
  • Six Sigma Green Belt certification or experience with formal investigative techniques

Stryker Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Stryker and has not been reviewed or approved by Stryker.

  • Healthcare Strength — Multiple medical plan options with HSA support and global mental‑health access indicate broad, accessible care. These features materially enhance the overall value of the total‑rewards package.
  • Retirement Support — A meaningful 401(k) company match with potential additional company contribution, alongside an ESPP, supports long‑term savings and wealth building. Documented plan specifics help employees understand eligibility, timing, and vesting mechanics.
  • Parental & Family Support — Paid parental and caregiver leave, adoption and surrogacy assistance, and practical supports like breast milk shipping reflect a comprehensive, family‑friendly approach. These offerings address varied family‑building paths and caregiving needs.

Stryker Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Portage, MI
51,000 Employees
Year Founded: 1941

What We Do

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com. Together with our customers, we are driven to make healthcare better.

Gallery

Gallery

Similar Jobs

Gradient AI Logo Gradient AI

Data Engineer

Artificial Intelligence • Insurance • Machine Learning • Software • Analytics
Easy Apply
Remote or Hybrid
USA
130 Employees
130K-150K Annually
In-Office
Portage, MI, USA
956 Employees
70K-168K Annually
In-Office
Portage, MI, USA
956 Employees
78K-130K Annually

Stryker Logo Stryker

Senior Engineer

Healthtech • Other • Robotics • Biotech • Manufacturing
In-Office
Portage, MI, USA
51000 Employees
78K-130K Annually

Similar Companies Hiring

Ford Energy Thumbnail
Automotive • Software • Energy • Utilities • Manufacturing • Renewable Energy
Glendale, Kentucky
55 Employees
Revel Thumbnail
Aerospace • Hardware • Robotics • Software
Marina Del Rey, California
70 Employees
Unusual Machines, Inc. Thumbnail
Hardware • Robotics
Orlando, FL
300 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account