Stryker Senior Complaint Specialist in Minnesota
Responsible for performing activities associated with complaint file processing, investigations, and preparing files for closure, including inputs from production, change control, risk management and other departments as needed. Reviews complaints and develops procedures for complaint handling systems that are within FDA and ISO guidelines. Viewed as departmental resource.
Works under general supervision and instruction of more experienced staff.
Provide guidance for using complaint related tools and resources.
Communicate directly with customer and internal company resources to complete information needed for the complaint file.
Clarify information provided during the Intake process to provide better clarity surrounding event descriptions.
Utilize risk management process to determine potential and actual risk related to complaint events.
Monitor and facilitate product return for complaint investigation and analysis.
Plans, conducts and executes assignments, reviewing progress and evaluating results.
Determine product failure root causes and evaluate risk of failures.
Investigate related failures, design, and manufacturing history of failed devices.
Maintains product expertise related to specific assigned products to guide and coach others on team, including mechanical function of the product and clinical applications.
Review complaints for completion, accuracy, and consistency.
Recommends changes in procedures when indicated.
Track and report on complaint progress and completion.
Prepare and complete complaint summary report updates for company.
Other duties as assigned.
- Bachelor’s Degree or equivalent experience required.
- Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Regulatory Affairs Certification (RAC), and/or advanced degree in related field preferred
Work From Home: No
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.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com