Product Complaint Specialist

Work Flexibility: Onsite

Stryker is hiring a Product Complaint Specialist in Irvine, CA! In this role, you will drive accurate and timely complaint processing that ensures device performance meets global standards. You’ll make an essential impact by transforming data into action and supporting continuous improvement across our devices and quality systems.

What You Will Do

• Review product documentation, analyze trending data, and submit required information to support compliant complaint processing.

• Maintain complete and accurate complaint records in alignment with U.S. and international regulatory requirements.

• Process customer complaints within defined timelines and ensure all required information is collected and documented for regulatory decision‑making.

• Assess clinical and technical information to support thorough investigations, root‑cause analysis, and quality engineering review.

• Prepare customer response letters and support clear, timely communication with internal teams.

• Assist during FDA and Notified Body inspections by providing documentation and process expertise.

• Coordinate and participate in cross‑functional meetings with Engineering, R&D, Marketing, Customer Service, and Technical Services.

• Generate reports to support rapid review of new complaints, regulatory submissions, and follow‑up actions.

• Escalate product trends and potential issues to appropriate stakeholders for evaluation and disposition.

• Conduct failure analysis on returned devices as required and apply device risk‑management knowledge to complaint evaluations.

What You Will Need

Required Qualifications

• Bachelor’s degree required. Focus on Engineering, Science, or a related field is beneficial.

• Minimum 0 years’ experience.

Preferred Qualifications

• Internship experience in quality, engineering, manufacturing, or related technical functions within regulated industries is strongly preferred.

• Knowledge of quality management system concepts, including good documentation practices, corrective and preventive action processes, and document control.

• Experience supporting complaint handling or quality engineering in medical devices.

• Familiarity with regulatory reporting requirements such as Medical Device Reporting under 21 CFR 803.

$71,800- $101,100 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: None

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.