Senior Quality Engineer

Stryker Corporation; Irvine, Northern (CA, KY); Hybrid; Confidential; Full time

Job summary

Stryker Corporation is seeking a Senior Quality Engineer for its Peripheral Vascular division in Irvine, CA, onsite. You will partner with operations and suppliers to drive product/process quality, manage nonconformances, CAPAs, and MRB, and support supplier certifications.

You will analyze quality data, mentor teams, and ensure regulatory compliance across the quality system. The role requires a Bachelor's in a science/engineering field and at least 2 years in quality engineering, with

Qualifications

• Bachelors degree in science, engineering or related discipline.
• At least 2 years in quality engineering with knowledge of quality systems, risk management, CAPA, auditing, and statistics.
• Experience applying risk management and compliance risk assessments in regulated environments.
• Proficiency with MS Office for data analysis and reporting.
• Experience with test method validation, protocols, reports and MSA/Gage R&R.
• Experience leading supplier quality activities and supplier corrective actions.
• Preferred CQE/CRE and Six Sigma Green/Black belt; medical device knowledge a plus.
• Familiarity with ISO 13485, 21 CFR Part 820, GDP, GMP; regulatory inspections exposure.

Responsibilities

• Drive product and process quality, resolve issues, and promote continuous improvement.
• Own nonconformances, CAPAs, MRB, and product disposition with timely investigations and root cause analysis.
• Collaborate with suppliers on corrective actions, supplier changes, PPAP, and part certification.
• Monitor and report quality metrics using statistics and risk management.
• Support manufacturing-related complaints, field actions, and containment activities.
• Develop and update quality system docs, procedures, inspection methods, sampling plans, and HF practices.
• Assist in process, equipment, and supplier validations/qualifications, MSA, and manufacturing transfers.
• Participate in internal/external audits and provide quality SME support for regulatory compliance.

Skills

Quality engineering

CAPA

Risk management

Auditing

Statistical methods

MSA

Supplier quality

Gage R&R

PPAP

Microsoft Office

Education

Bachelors in science/engineering

Tools

Microsoft Office

Gage R&R

Job description

Work Flexibility: Onsite Stryker is hiring a Senior 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 will 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.

What you need

• Bachelors degree in a science, engineering or related discipline
• Minimum of 2 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.
• Experience developing and executing test method validations, including authoring and revising protocols, reports, procedures, and/or work instructions, as well as conducting measurement system analyses (e.g., Gage R&R).
• Experience managing supplier quality activities, including supplier qualification, performance monitoring, and quality issue resolution.
• Preferred CQE, or CRE and Six Sigma Green or Black belt preferred
• 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.
• Experience developing, programming, and validating automated inspection programs, protocols, and recipes for manufacturing or quality inspection systems.

$89,400 - $148,900 USD Annual Travel Percentage: 0%

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.