New · posted Oct 15
Stryker · Medical Devices
Staff 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 development, transfer, and introduction of new medical devices, manufacturing processes, and technologies. In this role, you will provide technical quality leadership across design transfer, process validation, risk management, inspection strategy, supplier quality, and manufacturing readiness within a regulated environment.
What you need
Required
- Bachelor of Science degree in Engineering or a related technical discipline.
- Minimum 4 years of experience in quality, engineering or technical discipline
- Experience in a regulated manufacturing environment.
- Experience with risk-based and statistical quality techniques, including FMEA, statistical sampling, process capability, and MSA.
Preferrednice to have
- Experience in new product or process introduction.
- Certified Quality Engineer (CQE) certification or equivalent quality engineering coursework or experience.
- Experience with medical device manufacturing and applicable quality requirements, including ISO 13485, Good Manufacturing Practices, and Good Documentation Practices.
- Lean Six Sigma training and experience applying structured problem-solving methods such as DMAIC.
- Experience with supplier qualification and supplier quality activities supporting new product introduction and manufacturing.
$102,700 - $171,100 USD Annual
What you'll do
- Lead quality engineering activities for new product and process introductions, ensuring design transfer deliverables are completed, documented, and aligned with quality and regulatory requirements.
- Evaluate manufacturing and process risks using Process Failure Mode and Effects Analysis (PFMEA), identify mitigation and control strategies, and support risk management activities in accordance with ISO 14971.
- Develop inspection strategies, sampling plans, First Article Inspection approaches, and Measurement System Analysis (MSA) strategies that support repeatable, scalable, and efficient manufacturing.
- Develop and approve process validation strategies, protocols, reports, and data analyses to support capable, scalable manufacturing processes and high production yield.
- Apply statistical methods and structured problem-solving tools to process characterization, capability analysis, nonconformances, corrective and preventive actions, root-cause investigations, and process improvements.
- Support Design for Manufacturing and Assembly by influencing process design, production specifications, inspection optimization, tooling, fixtures, and human-error risk controls.
- Lead quality activities for supplier qualification, supplier validation, Production Part Approval Process (PPAP), supplier certification, and quality agreements.
- Represent Quality during design reviews and design transfer, tracking launch-quality measures including right-first-time performance, manufacturing loss, inspection cost, and product escapes.
Pay
$102,700 – $171,100 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 12% above 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 | $102,700 | — | $171,100 |
| 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 compliance5
- Validation and qualification4
- Collaboration and leadership4
- Documentation and SOPs3
- Lab testing and methods2
- 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%
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Staff Quality Engineer, New Product Introduction at Stryker
Open until filled. $103K–$171K a year, employer provided.