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New · posted Oct 22

Stryker · Medical Devices

Senior Quality Systems Specialist

  • Redmond, WA
  • Hybrid
  • Full-time
  • Senior & Principal
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Pay$83K–$139Ka year · employer provided
EmploymentFull-time
LocationRedmond, WAHybrid
LevelSenior & Principal
FunctionQuality AssuranceQuality
Deadline

Open until filled

The role

Work Flexibility: Hybrid

As a Senior Quality Systems Specialist, you will play a critical role in ensuring the effectiveness of Stryker's quality management system by driving compliance, leading problem-solving efforts, and partnering with cross-functional teams to resolve quality issues. This position offers the opportunity to influence quality excellence, continuous improvement, and regulatory compliance across the organization. This role is Hybrid in Redmond, Washington.

What You Need

  • Bachelor’s degree in Science, Engineering, or a related discipline.
  • Minimum 3+ years of experience in a manufacturing environment or equivalent.
  • Strong communication, project management, and influencing skills.
  • Demonstrated ability to manage multiple priorities in a fast-paced, matrixed environment.
  • Strong analytical, critical thinking, and problem-solving capabilities.
  • Ability to work independently and drive issues to resolution.
  • Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.

What you need

Preferrednice to have

  • 2+ years of experience in CAPA, Quality Systems, Quality Engineering, or a related field.
  • Experience interacting with regulatory agencies such as FDA, TUV, and other international regulatory bodies.
  • Knowledge of U.S., European, and international medical device regulations and standards.
  • Strong understanding of quality system processes, including audits, management review, and quality planning.
  • Experience working in compliance-risk environments.
  • Demonstrated success leading projects and driving results across cross-functional teams.
  • Excellent written, verbal, and negotiation skills.
  • Ability to facilitate teams through complex investigations and root cause analyses.
  • Experience supporting multi-site or global quality initiatives.
  • Willingness to travel as needed.

Skills named in this posting

What you'll do

  1. Own and oversee the Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes to ensure compliance, effectiveness, and efficiency in addressing quality issues.
  2. Review and approve NCs and CAPAs for completeness, accuracy, effectiveness, and timeliness.
  3. Partner with cross-functional teams to facilitate investigations, root cause analysis, and corrective action implementation.
  4. Serve as the site subject matter expert and super user for the eCAPA system, ensuring records are maintained with appropriate supporting evidence..
  5. Coach and mentor teams on problem-solving methodologies, including 5 Whys, Fishbone Diagrams, Process Mapping, Human Error Reduction, and 4-D methodologies.
  6. Lead accountability meetings, CAPA review boards, and root cause analysis workshops to drive quality improvements.
  7. Monitor and report NC/CAPA key performance indicators (KPIs), providing updates for quality and business review forums.
  8. Develop, maintain, and deliver training programs related to CAPA processes and quality systems.
  9. Identify and implement continuous improvement initiatives to optimize quality systems and business processes.
  10. Participate in cross-site and corporate quality system improvement projects.
  11. Support internal, corporate, customer, and third-party audits, including preparation, participation, and follow-up activities.

Pay

$83,400 – $139,000 a year

Employer provided
How this compares

United States of America Pay Ranges

  • US15: $83,400 - $139,000 USD Annual

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

Where you'll work

Redmond, WAHybridOpen in Maps (opens in a new tab)

More jobs in Redmond, WA
Equal opportunity, accessibility and legal noticesStryker's statements, word for word

Travel Percentage: NoneStryker 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.

Job intelligence

The context around this role

Live data · October 23, 2026

Salary intelligence

How the pay compares

This role's midpoint is 7% below the US median for Quality Assurance roles at this level.

This roleEmployer provided

$83,400 to $139,000 a year

Senior & Principal roles in the US313 roles publishing pay

Middle half $102,500 to $137,500, median $119,000
Annual base pay
Annual base payLowMedianHigh
This role$83,400—$139,000
All US$102,500$119,000$137,500

This role: Stryker's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Quality Assurance

The general path across 927 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Stryker's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Quality Engineer · Quality Technician

    $81K median251 open

  2. This role

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $119K median394 open

  3. Next step

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $153K median144 open

  4. Later

    Director

    Often: Director, Quality · Associate Director, Quality Assurance

    $209K median121 open

  5. Later

    VP & Executive

    Often: AVP · DX Head of Regions Quality Management and Regulatory Affairs

    $302K median17 open

Career resources on Quality Assurance

Skills DNA

What this role leans on

How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 6 linesLab testing and methods: 2 linesDocumentation and SOPs: 2 linesInvestigations and CAPA: 7 linesQuality systems and risk: 6 linesData and digital systems: 1 lineCollaboration and leadership: 8 linesGMPLab testingDocumentationInvestigationsQuality systemsData systemsTeamwork
  • Collaboration and leadership8
  • Investigations and CAPA7
  • GMP and compliance6
  • Quality systems and risk6
  • Lab testing and methods2
  • Documentation and SOPs2
  • Data and digital systems1

Company hiring pulse

Stryker on Regulatory Jobs

67
Open roles
55
Distinct roles
18
Locations

By discipline

  • Quality54 81%
  • Regulatory11 16%
  • Compliance & Safety2 3%

By level

  • Senior & Principal41 61%
  • Associate & Specialist19 28%
  • Manager7 10%
See all 67 Stryker roles

More roles at Stryker

All 67 Stryker roles

Similar Quality Assurance roles elsewhere

Senior Quality Systems Specialist at Stryker

Open until filled. $83K–$139K a year, employer provided.

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