Product Complaint Specialist

Stryker•Irvine, CA

5d•Onsite

About The Position

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.

Requirements

Bachelor’s degree required.
Focus on Engineering, Science, or a related field is beneficial.
Minimum 0 years’ experience.

Nice To Haves

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.

Responsibilities

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.