Product Complaint Specialist
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Job Location:
Irvine, CA - USA
Monthly Salary:
$ 71800 - 101100
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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. Youll 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 decisionmaking.
Assess clinical and technical information to support thorough investigations rootcause 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 crossfunctional meetings with Engineering R&D Marketing Customer Service and Technical Services.
Generate reports to support rapid review of new complaints regulatory submissions and followup 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 riskmanagement knowledge to complaint evaluations.
What You Will Need
Required Qualifications
Bachelors 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.
$71800- $101100 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.
Travel Percentage: NoneStryker 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 contractors legal duty to furnish information.Required Experience:
IC
Key Skills
- Sales Experience
- Marketing
- Customer Service
- Communication skills
- Military Experience
- Retail Sales
- Product Demos
- Customer Support
- Product Management
- Product Development
- Unity
- Microscopy
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
