Medical Device Complaint Analyst

Full Time
Valhalla, NY 10595
Posted Today
Job description
Summary
Plan, perform, evaluate and document laboratory experiments to provide valid data on current or potential products, components or processes. Conduct troubleshooting and product evaluations including preparation and testing with blood samples. Prepare specifications procedures and protocols, and evaluate customer complaints, inquiries and satisfaction issues.
Analyze materials or finished products according to established procedures and as directed by supervisor.

Record and report results in a manner acceptable for legal purposes. Provide interpretive commentary and analysis as necessary. Provide statistical analysis for reports leading to Technical Review, process or product evaluations, and process product qualifications as directed by supervisor.

Perform necessary testing to assure the validity of the testing procedures as directed by supervisor.

Report deviant results and design alternate experimental protocols to identify problems or to provide solutions. Prepare reports on new or ongoing product quality assurance for management as directed by supervisor.

Continue to develop expertise in the quality systems assigned. Be able to assist as an advisor to Quality personnel on issues.

Network with scientists/engineers to be aware of scientific projects and relationships to assigned area of responsibility.

Perform special assignments as directed by supervisor.

Resolve technical and Quality problems and questions for countries and provide technical support.

Coordinate the handling of potential adverse information.

Coordinate implementation of corrective actions determined as a result of adverse information. Determines appropriate test methods/protocols for investigation of process, product and/or component evaluations. Recommendations made by this position will influence preventative and corrective actions taken in product design, process control and customer interactions. Amount of supervision is moderate to minimal. Consults with supervisor at pivotal points in projects.

Qualifications
Bachelor’s degree in the sciences emphasizing chemistry, life sciences or Medical Technology.

Understanding of valid experimental design and interpretation and command of basic clinical laboratory techniques.

Able to effectively analyze results of experimentation, evaluations and testing and able to summarize and report findings.

Strong knowledge of statistical analysis

Excellent computer skills, solid knowledge of MS Excel

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