The Senior Associate PQC Investigator, Global Product Quality – Global GMP Processes and Devices supports Product Quality Complaint activities by coordinating complaint intake, conducting investigations, documenting findings, and assisting with complaint resolution for commercial medical devices, combination products, and medicinal products. Support the intake, documentation, coordination, investigation, resolution, {replacement/reimbursement} and closeout) of Product Quality Complaints in timely manner that complies with Otsuka requirements and Regulatory requirements (21CFR Parts 210, 211, 820, 803).