Senior Engineer, Quality Assurance

Stryker; Redmond (WA); Hybrid; USD 90,000 - 150,000; Full time

Job summary

Stryker Corporation in Redmond, WA is seeking a Senior Quality Assurance Engineer to lead Emergency Care investigations and drive post-market improvements across the product lifecycle. The role supports a hybrid work model with onsite presence several times per week, serving Redmond, WA or Portage, MI.

Responsibilities include containment actions, CAPA management, cross‑functional collaboration, audits, and ensuring timely, compliant documentation while upholding risk management standards across

Qualifications

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

Responsibilities

• Lead product field action assessments from initiation through review and approval, ensuring documentation.
• Investigate complex product quality issues using structured problem-solving and root cause analysis.
• Perform post-market health risk assessments and health hazard evaluations for patient safety.
• Develop containment recommendations and corrective actions based on findings and quality data.
• Author and manage nonconformance and CAPA records with defined deliverables and timelines.
• Coordinate investigations and corrective action reviews with R&D, Manufacturing, Regulatory, Quality, Marketing, Service and suppliers.
• Represent QA processes during audits and maintain compliance with quality systems and risk management requirements.

Skills

Quality assurance

Root cause analysis

Regulatory understanding

Post-market quality assessments

Education

Bachelor's degree in science, engineering, or a related discipline

Master’s degree in science, engineering, or related discipline

Six Sigma Green Belt certification

Job description

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

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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility

• Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.
• Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.
• Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.
• Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.