Summary: The complaints investigation technical investigator will perform the device assessment of complaint samples using equipment such as the CT scanner, SEM material analysis, 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.
Responsibilities:
Perform device assessments of complaints and document results in a report.
Perform root cause analysis investigations for mechanical and/or electromechanical products
Complete evaluation and deliver assessment report on time per 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
Basic Qualifications
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
Demonstrated competency in root cause analysis methodology
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
Top 3 Must Have Skill Sets:
Strong technical, analytical and problem solving skills
Strong interpersonal, communication, and teamwork skills
Skills and experience in lab environment
Pay Transparency: The typical base pay for this role across the U.S. is:$ 32.00- $ 35.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
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