Tasks and Responsibilities
• Creates entries in calibration program for new equipment and completes calibration section of equipment qualification records
• Maintains calibration program: enters records of internal and external calibration, writes out-of-calibration reports and obtains approvals, maintains calibration files for all company equipment and associated repair records as required
• Schedules all calibrations including in-house performed by TSS personnel, in-house performed by vendors, and external calibrations
• Selects vendors for calibration program by obtaining quotes and evaluating vendor qualifications for ASL per appropriate process.
• Performs in-house calibrations of equipment not calibrated by Engineering or vendors and records results
• Determines frequency of calibrations and suggests modifications to frequency based on calibration history
• Prepares equipment and documents to return to the manufacturer for repair due to damage or out-of-tolerance calibration results
• Writes and revises work instructions, forms, and Quality Assurance procedures for calibrations, or other documentation related to calibration
• Maintains calibrations equipment and ensures its proper calibration
• Creates calibrations requirement sheet of each measurement machine and hand tools according to procedure, and retrieves and uses during internal and external calibrations
• Verifies certificate of calibration and data done by on-site and outside vendors
• Calculates minimum tolerance and updates appropriate documentation for new machines or gauges used in production
• Sets the alarm limits of the Temperature Humidity Records each time they are back from calibration or as needed to control the environment of storage material
• Maintains EMP (Equipment Monitoring Program) system to control accuracy of measurement equipment
• Coordinates equipment movement with concurrent calibration, if applicable
• Assists with inspection equipment selection
• Controls the accuracy of working standards, gauges, instruments, and equipment used to calibrate other gauges and equipment
• Initiates internal and vendor CPA’s
• Sets up and verifies that preventive maintenance of measurement equipment is complete at the time of calibration
• Investigates and resolves calibration issues.
• Understands the ISO room certification to request appropriate quotes for re-certification.
• Processes and maintains workmanship standards records
• Maintains training records for QA and QC
• Maintains Annual Documentation Review for TSS
• Support site internal and customer-requested auditing activities
• Support and reinforce GDP/GDM behaviors and continuous improvement efforts.
• Other duties and responsibilities as assigned.
Education and Experience
Required:
- 2 years of experience in a calibration role (Medical Device preferred)
- Demonstrated understanding of QSR and ISO standards for Equipment Controls
Desired:
- 2 year degree in Manufacturing, Engineering or related field
Competencies
- Ability to read, write, speak and understand the English language
- Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
- Ability to demonstrate adequate job knowledge to deliver a world class performance
- Ability to challenge oneself to consistently meet all goals and deadlines
- Willingness to strive for excellence by producing work that is free of errors and mistakes
- Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
- Commitment to making improvements company wide
- Demonstrated mid-level skills using Microsoft Office
- Expert user of calibration software program
- Proven organizational skills
- Good math skills
- Comprehensive understanding of applicable Work Instructions, SOP’s & QAP’s
- Ability to work with minimal supervision and make sound decisions
- Good manual dexterity with mechanical aptitude
- Correctable normal reading distance vision
- Ability to maintain a professional and respectful relationship with coworkers and company
Travel:
Minimal travel as required
As an EEO/Affirmative Action Employer all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status.