Join Stryker’s Instruments Division in Portage, MI, as a Complaint Specialist, where your work will directly support patient safety and product quality around the world. In this high‑impact role, you will transform complex product events into clear regulatory actions that help protect patients, clinicians, and our brand. This is an opportunity to grow your expertise in post‑market surveillance within a collaborative, mission‑driven environment.
What You Will Do
Review and assess incoming product complaints to determine reportability in accordance with MDR, MIR, and global regulatory requirements.
Prepare and submit well‑written adverse event reports within required timeframes to regulatory authorities.
Develop clear, data‑driven rationales for non‑reportable events using risk documentation, product knowledge, and clinical input.
Conduct customer follow‑up to obtain missing complaint details and coordinate product returns for analysis.
Initiate nonconformance records in the electronic quality system and maintain documentation accuracy for all complaint files.
Analyze complaint data to identify trends, recurring failure modes, and potential patient impact.
Investigate device performance by reviewing product design, manufacturing history, and related failures.
Respond to requests for additional information from global regulatory agencies in partnership with senior staff.
Support internal and external regulatory audits through timely documentation and subject‑matter insights.
Contribute to post‑market activities including recall assessments, recall communications, and product quarantine management.
What You Need
Bachelor’s degree (B.S. or B.A.) required.
0 years of relevant work experience required.
Travel Percentage: 10%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.