Quality Complaints Investigation Engineer

• Able to collaborate and communicate with cross functional team
• Experience in technical investigation and root cause analysis

Onsite 80%, must be available to go onsite when needed - Hybrid

Expectation is that they will need to be onsite.

Preferably Local candidates

Work Schedule:

Dayshift

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. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and cross-functional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner.

Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis, as well as supporting/leading root cause analysis.

S/he will also support the implementation, validation, and operation of the equipment in the lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, participating in the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.

• Perform device assessments of complaints and document results in a report.
• Complete evaluation and deliver assessment report on time per Amgen 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

• 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.

• 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

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience