Stryker · 10 hours ago
Complaint Specialist (Hybrid)
Portage, Michigan
Full-time
Hybrid
New Grad, Entry Level
0+ years expStryker is a global leader in medical technology, and they are seeking a Complaint Specialist to support patient safety and product quality. In this role, you will transform complex product events into clear regulatory actions and help protect patients and clinicians.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
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
Qualification
Required
Bachelor's degree (B.S. or B.A.) required
0 years of relevant work experience required
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase