Stryker · 7 hours ago
Product Complaint Specialist
Irvine, California
Full-time
Onsite
New Grad, Entry Level
$72K/yr - $101K/yr
0+ years expStryker 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, transforming data into action and supporting continuous improvement across devices and quality systems.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
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
Qualification
Required
Bachelor's degree required. Focus on Engineering, Science, or a related field is beneficial
Minimum 0 years' experience
Preferred
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
Benefits
Bonus eligible
Benefits
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase