Complaints Investigation Technical Investigator

Complaints Investigation Technical Investigator Hybrid Summary Our company is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Sr. Engineer in Complaints Trending and Investigation group. In support of our mission to serve patients, the Complaints Trending and Investigation group is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience. The complaints investigation technical investigator will perform the device assessment of complaint samples using lab equipment such as the CT scanner and Instron testing machines. The investigator will be responsible for authoring the assessment report, communicating the findings and results to management and cross‑functional teams, and maintaining the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner and support investigations by performing characterization testing, data gathering and analysis, as well as supporting/leading root cause analysis. The investigator will also support the implementation, validation, and operation of the equipment in the lab; provide personnel training on equipment use, develop and update procedures, participate in monthly lab safety inspections, and identify and report equipment repairs or maintenance. The investigator will work with vendors to resolve issues and suggest improvements associated with the operation of the equipment. Responsibilities Perform device assessments of complaints and document results in a report. Complete evaluation and deliver assessment report on time per company requirements. Support the implementation and management of the lab infrastructure, including all equipment used for investigations. Provide requirements for lab and investigational equipment to device development teams in support of new device platforms. Support characterization testing and data gathering for investigations. Perform root cause analysis investigations for mechanical and/or electromechanical products. Requirements Master’s degree; OR Bachelor’s degree and 2+ years of related medical/biopharma development or Operations experience; OR Associate degree and 6+ years of related medical/biopharma development or Operations experience. Preferred Qualifications Master’s or Bachelor’s in Engineering, Science or Biomedical. 2+ years of experience in complaints investigation within a development, manufacturing, post‑market or equivalent environment. Experience in lab environment. Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP). Strong technical writing and interpersonal skills. Results‑driven and detail‑oriented. Strong sense of responsibility and time management. Demonstrated competency in root cause analysis methodology. Pay and Benefits $35 - $40 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Compensation reflects cost of labor across several US geographic markets and may vary based on market location, knowledge, skills, and experience. #J-18808-Ljbffr Crystal Equation Corporation