Senior Quality Engineer

Stryker; Irvine (CA); On-site; USD 89,000 - 149,000; Full time

Job summary

Stryker Irvine, CA is seeking a Senior Quality Engineer in the Peripheral Vascular division to provide quality assurance, control, and continuous improvement across manufacturing operations, products, and processes.

You will partner with cross-functional teams and suppliers to resolve quality issues, lead CAPAs, audits, and nonconformances, and ensure compliance with ISO 13485, FDA 21 CFR 820, GDP, and GMP.

The role emphasizes data-driven decision making and QMS documentation.

Qualifications

• Bachelor's degree in science, engineering or related discipline.
• Minimum of 2 years of quality engineering experience with knowledge of risk management, CAPA, auditing, and statistics.
• Experience applying risk management principles and performing compliance risk assessments in regulated environments.
• Proficiency using MS Office to analyze data, create reports, and support cross-functional activities.
• Experience developing and executing test method validations and conducting Gage R&R analyses.
• Experience managing supplier quality activities, including supplier qualification and performance monitoring.

Responsibilities

• Partner with Operations, suppliers, and cross-functional teams to drive product and process quality and support continuous improvement.
• Own and support nonconformances (NCs), CAPAs, MRB activities, and product disposition with timely investigations and corrective actions.
• Collaborate with suppliers to address quality concerns, manage supplier corrective actions, evaluate supplier changes, perform PPAP, and support supplier part certification programs.
• Monitor, analyze, and report quality and process metrics using statistical methods and risk management to identify trends and improvements.
• Support manufacturing-related complaints, field actions, holds, and containment to ensure regulatory compliance and product quality.
• Develop, review, and improve quality system documentation, procedures, sampling plans, and Human Factors practices.

Skills

Quality engineering

Risk management

CAPA

Auditing

Statistics

MS Office

Education

Bachelor's degree in science or engineering

CQE/CRE or Six Sigma Green/Black belt

Tools

Microsoft Office

Job description

## Senior Quality EngineerApplylocations: Irvine, Californiatime type: Full timeposted on: Posted Todayjob requisition id: R568124Work 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:****Required*** 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 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 AnnualTravel 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.