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Calibration Quality Specialist
2 months ago
Exergen Corporation is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever previously possible.
Our Temporal Scanner™ is the most efficacious, non-invasive thermometer ever created. Exergen holds over 100 issued and pending U.S. and foreign patents, and is the only manufacturer of retail medical thermometers in the U.S. Presently, half of hospitals and pediatricians currently use the Exergen Temporal Scanner, and well over 14 million consumers use one at home.
Founded by Harvard-research scientist, Dr. Francesco Pompei, over three decades ago, Exergen Corporation is based in Watertown, Massachusetts, USA.
Calibration Quality Specialist
Job Description
Perform calibrations to in–house assets ranging from simple hand-tools to complex test equipment.
- Function as main point of contact with external calibration vendors to resolve all issues and coordinate efforts.
- Conduct routine testing of equipment per work instruction documentation.
- Perform maintenance of equipment per work instruction documentation.
- Repair equipment of equipment per work instruction documentation.
- Prepare reports including Work Orders (WO), IQs, and more.
- Review external vendor certifications for completeness and accuracy.
- Assist as required with OOT investigations and reviews.
- Train calibration procedures as required to enhance personal skillset.
- Apply existing work methods to different situations and solve problems ranging from recurring/routine to complex situations.
- Utilizing various measurement/test equipment and computers, calibrates electronic test measuring equipment and signal generating equipment to conform to set standards.
- Assesses, calibrates, adjusts, and maintains measuring and indicating instruments.
- Writes calibration procedures, prepares documentation, inputs data, and generates reports.
- Sets up calibration sequences, methods, and procedures according to detailed specifications, documents, drawings, and requirements.
§ Applies theoretical principles, evaluation, ingenuity, and creative/analytical techniques to identify route cause of calibration problem.
§ May serve as lead and assign work to less experienced personnel; reviews work of lower-level employees for quality and content; serves as a mentor when assisting less experienced staff in solving more complex problems.
§ Working environment varies from standard office/cubicle with air/sound/light control to general laboratory and production areas with varying physical conditions.
EDUCATION AND EXPERIENCE
· Technical Degree or Certificate
· ASQ Certified Calibration Technician (CCT) is prefer.
· 7+years of working experience as a Calibration Engineer in Regulated Industries.
· Requires demonstrated knowledge/understanding of GMP, other key practices and procedures of the function, company products, polices, and programs.
· Proficient in using various PC-based document control software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software.
· The ability to read, write, and communicate effectively with other departments.
· Support external audits.
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