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Calibration Analyst III (QMS)
Ref No.: 18-11091
Location: San Diego, California
Summary
Under general supervision, this position is responsible for calibration and other metrology activities in support of company production and quality objectives.


Tasks and responsibilities:

• Develop methods for calibration of various instruments using accepted metrology and industry practices.
• Calibrate instruments.
• Troubleshoot equipment and system malfunctions or arrange for repair as appropriate.
• Coordinate and perform in-house equipment calibration verifications according to written procedures.
• Provide training and guidance regarding the calibration program with other departments as needed.
• Develop equipment calibration procedures in accordance with established guidelines
• Provide direct communication with service providers reviewing their calibration documentation, coordinate and supervise onsite visits ensuring compliance with current requirements and standards.
• Provide Guidance regarding completion of out of tolerance reports.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Client's Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Perform other duties & projects as assigned.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.




Preferred educational background:
AS or BS in technical field or equivalent.

Preferred experiential background:
• Five to eight years of calibration-related experience.
• Controls and/or instrumentation or equivalent professional training.
• Knowledge of basic cGMP calibration requirements preferably in vitro diagnostics.
• Experience with 21 CFR 820, ISO 13485.
• Strong working knowledge of instrumentation and control systems
• Thorough understanding of good calibration practices.
• Experience with a calibration management database application.
• Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.
• Must be detail-orientated, self-motivated and available for flexible scheduling.
• Strong communication, problem solving and motivational skills.
• Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with minimal supervision.
• Ability to interact effectively with all levels of the organization and perform multiple tasks in a fast paced environment.
• Strong proficiency in using MS Office, WORD, Excel, Visual Basic, Access, MS Project, Visio and other data systems (JDE)
• Excellent written and verbal communication skills
• Able to handle multiple tasks and must present exceptional prioritizing and organization skills.