Clinical Evaluation Expert

Conduct clinical evaluations for our customers

Essential Duties and Responsibilities include, but are not limited to, the following:
Includes all aspects of clinical evaluation and PMS for medical devices.
Assists/contributes in all areas of production as needed.
Reviews, edits, completes, and revises completed batch records, Logbooks.
Ensures availability of production batch records for upcoming lots.
Performs manufacturing level maintenance on equipment.
Monitors production processes.
Participates in equipment start-up, commissioning, and validation activities.
Ensures equipment operational readiness.
Assist with troubleshooting in case of equipment failure.
Gathers, trends, and analyzes process generated data.
Participates in defining robust process parameters during routine manufacturing campaigns.
Works to optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaigns.
Creates process evaluation reports, process transfer documentation, and process characterization presentations.
Documents all training;
Assist with training of new employees.
Performs various tests and analytical procedures.
Performs in-process sampling, Quality Control Chemistry and Quality Control Microbiology.
Keeps process area stocked with essential equipment and components.
Ensures all tasks are performed in a manner consistent with safety standards.

 Please apply by email to Career @ Orange-Moon