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’re making 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.
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.
Salary
$71,800‑$101,100 plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Benefits
include medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include HSA, FSAs, 401(k) plan, ESPP, basic life and AD&D insurance, and short‑term disability insurance.
Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various as an essential function of their role.
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In this role, you will drive accurate and timely complaint processing that ensures device performance meets global standards. You’re making 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.
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.
Salary
$71,800‑$101,100 plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Benefits
include medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include HSA, FSAs, 401(k) plan, ESPP, basic life and AD&D insurance, and short‑term disability insurance.
Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various as an essential function of their role.
#J-18808-Ljbffr