Staff Quality Assurance Engineer

Regulatory Jobs; Irvine (CA); On-site; USD 103,000 - 171,000; Full time

Job summary

Stryker is seeking a Staff Quality Engineer to join the Peripheral Vascular division in Irvine, CA. Onsite role supporting quality assurance, quality control, and continuous improvement across manufacturing operations, products, and processes.

Collaborate with cross‑functional teams and suppliers to resolve quality issues and drive CAPA, NCRs, and product disposition, ensuring compliance with regulatory requirements.

Qualifications

• Bachelor's degree in science, engineering, or related field.
• At least 4 years in quality engineering with CAPA, auditing, and statistics.
• Experience with risk assessments in regulated environments.
• Proficient in data analysis and reporting with MS Office.

Responsibilities

• Drive product and process quality performance with cross-functional teams.
• Own nonconformances, CAPAs, MRB, and product disposition.
• Collaborate with suppliers on supplier quality and PPAP.
• Monitor quality metrics and apply statistical methods.
• Support audits and regulatory compliance.
• Develop and maintain quality system documentation.
• Participate in internal and external audits.

Skills

Quality engineering

CAPA & audits

Risk management

Statistical analysis

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Tools

Microsoft Office

Quality management software

Job description

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 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 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.

Preferred

• 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

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.