Complaint Specialist (Hybrid)

Stryker•Portage, MI

13h•Hybrid

About The Position

Join Stryker’s Instruments Division in Portage, M I, 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.

Requirements

Bachelor’s degree (B.S. or B.A.) required.
0 years of relevant work experience required.

Responsibilities

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.