Perform routine and special calibration of all equipment/test and instruments measurement included in the calibration system to effectively meet the requirements and specifications in the General Calibration Procedure.
Key Responsibilities:
• Plan and perform more complex calibration of equipment with certifications and/or training in measurement; ensure all calibration documentation are entered into system and in compliance, including the review of calibration, Preventive Maintenance (PM) and First Article Inspection (FAI) reports
• Register (induct) new equipment and maintain all metrology equipment (calibration and preventive maintenance) in computerized maintenance management system (CMMS)
• Verify calibration report meets the calibration requirements as stated in asset record or by standards, and escalate any discrepancies
• Coordinate with service providers and custodians for calibration. Participate in the development and implementation of calibrations processes and procedures, including identifying opportunities for modification and making recommendations. Participate in investigations of non-conformities in different systems
• Participate in Out-of-Tolerances (OOT) investigations as requested
• Act as CMMS (e.g Blue Mountain, Maximo) expert and provide training and technical expertise to all other users
• Research specifications for equipment and propose usage
• Provide coaching and guidance to technicians and other users
• Monitor and ensure all metrology laboratory requirements are met
• Other incidental duties
Education and Experience:
H.S. Diploma or equivalent 3 Years years experience measurement and calibration of equipment/instruments Required and
Associate's Degree or equivalent in electric, mechanical, electronics, and/or metrology Preferred
Additional Skills:
• Good communication skills
• Able to read, comprehend, write and speak English
• Good computer skills, including MS Office and advanced proficiency in CMMS (e.g Blue Mountain, Maximo)
• Substantial knowledge of calibration of manufacturing equipment and usage of hand tools, electronic monitoring equipment, fluid and pressure monitoring equipment
• Ability to utilize computerized maintenance management system
• Knowledge of calibration regulations and standards
• Moderate knowledge of SI Base Units (length, mass, time, electric current, thermodynamics temperature, amount of substance, luminous intensity)
• Ability to perform more complex troubleshooting
• Ability to identify problems and relevant issues in straightforward and more complex situations, assessing using standard procedures
• Ability to use a wider range of IM&TE (Inspection, Measurement, and Test Equipment)
• Ability to read and understand procedures, drawings, schematics and carry out assembly instructions
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Strict attention to detail
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Must be able to work in a team environment, including inter-departmental teams
• Ability to provide feedback in a professional, direct, and tactful manner
• Represents the organization to outside contacts, i.e., vendors
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.