Senior Calibration Quality Engineer

2 weeks ago

Watertown, Massachusetts, United States Exergen Corporation Full time

Exergen Corporation stands as the global leader in non-invasive medical temperature technology. With a commitment to innovation, Exergen has developed and manufactures advanced non-invasive temperature measurement devices that offer enhanced accuracy, reduced costs, and increased reliability.

Our flagship product, the Temporal ScannerTM, is recognized as the most effective non-invasive thermometer available. Exergen holds an extensive portfolio of over 100 patents, both issued and pending, and is the sole manufacturer of retail medical thermometers in the United States. Currently, our Temporal Scanner is utilized by approximately half of hospitals and pediatricians, with over 14 million households relying on it for home use.

Founded by Dr. Francesco Pompei, a Harvard-trained scientist, Exergen Corporation has been a pioneer in the field for over thirty years, with its headquarters located in Watertown, Massachusetts, USA.

Position: Lead Calibration Quality Specialist

Role Overview

Oversee the Manufacturing Calibration process within a regulated environment governed by FDA standards. Play a pivotal role in the transition of the Quality team to electronic documentation.

Key Responsibilities:

  • Assist the manufacturing team with daily production tasks.
  • Act as the primary liaison with external calibration vendors to address issues and coordinate activities.
  • Conduct routine equipment testing according to established work instructions.
  • Perform maintenance on equipment following documented procedures.
  • Generate reports including Work Orders (WO), Installation Qualifications (IQs), and additional documentation.
  • Review external vendor certifications for accuracy and completeness.
  • Support Out of Tolerance (OOT) investigations and reviews, applying analytical techniques to identify root causes of calibration issues.
  • Provide training on calibration procedures to enhance team skills.
  • Utilize various measurement and testing equipment to calibrate electronic test instruments to meet established standards.
  • Evaluate, calibrate, adjust, and maintain measuring and indicating devices.
  • Draft calibration procedures, prepare necessary documentation, input data, and produce reports.
  • Establish calibration sequences, methods, and procedures in accordance with detailed specifications and requirements.
  • May lead and assign tasks to junior personnel; review their work for quality and provide mentorship in resolving complex issues.

The work environment includes standard office settings with controlled air, sound, and light, as well as general laboratory and production areas with varying physical conditions.

Assist in maintaining the company's document control software system (such as ARINA or similar applications).

Qualifications:

  • Technical Degree or Certification required.
  • ASQ Certified Calibration Technician (CCT) preferred.
  • Minimum of 7 years of experience as a Calibration Specialist in regulated industries.
  • Demonstrated knowledge of Good Manufacturing Practices (GMP) and relevant procedures.
  • Proficient in using PC-based document control software, including Microsoft Word and Excel.
  • Strong communication skills to effectively interact with various departments.
  • Familiarity with supporting external audits.

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