Address
Form of workTasks 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:
Desired:
Competencies
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
• 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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
