New · posted Oct 30
Stryker · Medical Devices
Staff Quality Assurance Engineer
- Irvine, CA
- On-site
- Full-time
- Senior & Principal
The role
Work Flexibility: Onsite
Stryker is hiring a Staff Quality Engineer for our Peripheral Vascular division in Irvine, CA to provide Quality Engineering support for quality assurance, quality control, and continuous improvement activities across manufacturing operations, products, and processes. Partner closely with cross-functional teams and suppliers to resolve quality issues, drive corrective and preventive actions, and enhance overall quality performance. Lead and support initiatives that improve product quality, operational efficiency, and customer satisfaction while ensuring compliance with applicable regulatory requirements, industry standards, and quality system expectations.
What you need
Required
- Bachelors degree in a science, engineering or related discipline
- Minimum of 4 years of quality engineering experience with demonstrated knowledge of quality system principles, including risk management, CAPA, auditing, and statistical methodologies.
- Experience applying risk management principles and conducting compliance risk assessments within a regulated environment.
- Demonstrated proficiency using Microsoft Office tools to analyze data, create reports, and support cross-functional business activities.
Preferrednice to have
- Experience managing supplier quality activities, including supplier qualification, performance monitoring, and quality issue resolution.
- CQE, or CRE and Six Sigma Green or Black belt preferred Or related
- Experience in the medical device industry with knowledge of U.S. and international medical device regulations, including familiarity with ISO 13485, 21 CFR Part 820, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).
- Experience with regulatory inspections and audits, including direct interaction with regulatory agencies such as FDA, TUV, MoH, etc.
$102,700 - $171,100 USD Annual
What you'll do
- Partner with Operations, suppliers, and cross-functional teams to drive product and process quality performance, resolve quality issues, and support continuous improvement initiatives.
- Own and support nonconformances (NCs), CAPAs, MRB activities, and product disposition, ensuring timely investigation, root cause analysis, corrective actions, and closure within quality systems.
- Collaborate with suppliers to address quality concerns, manage supplier corrective actions, evaluate supplier changes, perform PPAP activities, and support supplier part certification programs.
- Monitor, analyze, and report quality and process performance metrics, applying statistical methods, process controls, and risk management principles to identify trends and drive improvements.
- Support manufacturing-related complaints, field actions, commercial holds, and containment activities to ensure product quality and regulatory compliance.
- Develop, review, and improve quality system documentation, procedures, inspection methods, sampling plans, and Human Factors practices that enhance product and process effectiveness.
- Support process, equipment, and supplier validations/qualifications, measurement system analysis (MSA), engineering changes, supplier-initiated changes, and manufacturing transfer activities.
- Participate in internal and external audits and provide quality subject matter expertise to ensure compliance with applicable quality system and regulatory requirements.
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: 10%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 30, 2026
Salary intelligence
How the pay compares
This role's midpoint is 11% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California98 roles publishing pay
Senior & Principal roles in the US325 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $102,700 | — | $171,100 |
| California (middle half) | $116,750 | $137,250 | $158,875 |
| All US (middle half) | $104,000 | $123,000 | $143,000 |
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 30, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 988 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 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk12
- GMP and compliance8
- Documentation and SOPs4
- Collaboration and leadership4
- Lab testing and methods3
- Investigations and CAPA3
- Validation and qualification2
- Data and digital systems1
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.
Company hiring pulse
Stryker on Regulatory Jobs
- 65
- Open roles
- 54
- Distinct roles
- 17
- Locations
By discipline
- Quality53 82%
- Regulatory11 17%
- Compliance & Safety1 2%
By level
- Senior & Principal39 60%
- Associate & Specialist19 29%
- Manager7 11%
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Staff Quality Assurance Engineer at Stryker
Open until filled. $103K–$171K a year, employer provided.