New · posted Oct 15
Stryker · Medical Devices
Senior Quality Engineer, New Product Introduction
- Irvine, CA
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
Work Flexibility: Onsite
Irvine, CA
Join Stryker’s Quality Engineering team supporting the introduction and transfer of new medical devices and manufacturing processes. In this role, you will provide quality engineering support across risk management, validation, inspection, supplier quality, and design transfer activities while partnering with Engineering, Manufacturing, Design Assurance, and Quality teams.
What you need
Required
- Bachelor’s degree in Engineering or a related technical discipline.
- Minimum 2 years of experience in quality, engineering or technical discipline
- Experience in a regulated manufacturing environment.
- Experience with risk management and process controls.
Preferrednice to have
- Experience in new product or new process introduction.
- Certified Quality Engineer (CQE) certification or equivalent quality engineering coursework or experience.
- Experience with medical device manufacturing and quality requirements, including ISO 13485, Good Manufacturing Practices, and Good Documentation Practices.
- Lean Six Sigma training and experience with quality and statistical tools such as PFMEA, MSA, process capability, statistical sampling, and DMAIC.
- Experience with supplier qualification and supplier quality activities supporting new product introduction and manufacturing.
$89,400 - $148,900 USD Annual
What you'll do
- Support new product and process introductions by executing and documenting quality engineering activities throughout design transfer and product launch.
- Apply risk management principles to process risk assessments, risk mitigation, process controls, and Process Failure Mode and Effects Analysis (PFMEA) in accordance with ISO 14971.
- Develop inspection strategies, sampling plans, First Article Inspection approaches, and Measurement System Analysis (MSA) strategies to support repeatable and scalable manufacturing processes.
- Support the development, execution, review, and approval of process validation protocols and reports, including sterilization validation activities when applicable.
- Apply statistical methods and quality engineering tools to evaluate process capability, identify risks, investigate nonconformances, and support corrective and preventive actions.
- Support Design for Manufacturing and Assembly through process design, inspection optimization, tooling and fixture development, and production specification development.
- Execute supplier quality activities, including supplier qualification, validation, Production Part Approval Process (PPAP), supplier certification, and Quality Agreements.
- Partner with cross-functional teams during design reviews and design transfer activities, documenting quality deliverables and transferring product and process knowledge to manufacturing and Quality Engineering teams.
Pay
$89,400 – $148,900 a year
Employer providedWhere you'll work
Irvine, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Irvine, CAEqual opportunity, accessibility and legal noticesStryker's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 3% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California84 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $89,400 | — | $148,900 |
| California (middle half) | $118,625 | $135,000 | $158,625 |
| All US (middle half) | $103,375 | $122,750 | $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 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Stryker's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk6
- GMP and compliance4
- Documentation and SOPs4
- Validation and qualification4
- Collaboration and leadership3
- Lab testing and methods1
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
Company hiring pulse
Stryker on Regulatory Jobs
- 56
- Open roles
- 47
- Distinct roles
- 17
- Locations
By discipline
- Quality45 80%
- Regulatory9 16%
- Compliance & Safety2 4%
By level
- Senior & Principal32 57%
- Associate & Specialist18 32%
- Manager6 11%
More roles at Stryker
- View role
Staff Quality Engineer, New Product Introduction
Irvine, CASenior & PrincipalMedical Devices$103K–$171K
- View role
Staff Software Design Quality Engineer
Portage, MI · HybridSenior & PrincipalMedical Devices$103K–$222K
- View role
Senior Quality Engineer
Kalamazoo, MISenior & PrincipalMedical Devices$89K–$149K
- View role
Senior Staff Quality Engineer
Arlington, TNSenior & PrincipalMedical Devices$103K–$171K
Similar Quality Assurance roles elsewhere
- View role
Senior Supplier Quality Engineer
iRhythmOrange County, CA · HybridSenior & PrincipalMedical Devices$99K–$129K
- View role
Senior Design Quality Engineer
iRhythmSan Francisco, CA +1 more · HybridSenior & PrincipalMedical Devices$138K–$180K
- View role
Sr. Supplier Quality Engineer I
Tandem Diabetes CareSan Diego, CA · HybridSenior & PrincipalMedical Devices$100K–$123K
- View role
Sr. Quality Engineer - Manufacturing
Tandem Diabetes CareCaliforniaSenior & PrincipalMedical Devices$110K–$121K
Senior Quality Engineer, New Product Introduction at Stryker
Open until filled. $89K–$149K a year, employer provided.