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Job Description:

Johnson & Johnson is hiring for a Calibrations Supervisor to join our team located in Shockwave Medical Costa Rica.

Position Overview

• The Calibrations Supervisor is responsible for being the subject matter expert (SME) on calibration for all new and existing equipment used in Manufacturing and Development. Will collaborate with Quality, Manufacturing, and R& D Engineers on equipment requirements and will be responsible for creating, releasing, and maintaining calibration documents that define the specifications for all equipment. This position will be responsible for managing calibration activities with vendors and equipment manufacturers to ensure all equipment is calibrated accurately and on time, will supervise or coordinate the work of technicians, and others who assist in specific assignments.

Essential Job Functions

• Responsible for direct supervision of Calibration technicians.
• May technically supervise or coordinate the work of technicians, and others who assist in specific assignments.
• Review, investigate, and disposition Non-Conforming Reports (NCRs) related to calibration.
• SME on calibration for all tools and equipment used in Manufacturing and R& D.
• Support new product development projects with the creation and release of calibration specifications.
• Collaborate with engineers to maintain and ensure that existing calibration documents are accurate and up to date.
• Manage both manual and automated calibration software systems to ensure tools and equipment are calibrated prior to use.
• Coordinate with calibration vendors and equipment manufacturers to ensure all tools and equipment are calibrated prior to their calibration due dates.
• Responsible for ensuring all post-calibration activities are performed, calibration, calibration certificate review and labeling requirements are met, and equipment is functioning properly before releasing for official use.
• In the event of an out of tolerance condition, work cross-functionally to assess the risk and product impact, and to resolve the problem.
• Support equipment calibration activities associated with the expansion of the manufacturing areas.
• Manage/Lead improvement projects related to equipment calibration and calibration management systems.
• Act as the on-site administrator for any calibration management software.
• Work with the Manufacturing Engineering group to ensure Preventive Maintenance is performed as scheduled.
• Maintain and ensure equipment files are accurate and up to date.
• Review, monitor, and trend calibration results for periodic reporting, and proactively identify equipment problems and improvements.
• May support operations and R& D with tooling, fixtures and prototypes for new and existing equipment used in the manufacture and development of company products.
• May assist with evaluating and ordering equipment that best fits project requirements.
• Work cross-functionally on root cause analysis to resolve equipment problems.
• Train vendors and cross-functional team members as needed on equipment requirements.
• May be required to support equipment validation activities.
• Other duties as assigned.

Requirements

• Bachelor´s Degree in a related engineering discipline with 3-5 years of related experience or 5 years of related experience in calibration.
• 1+ years of related experience on supervising/ managing people.
• 3+ years of related experience in manufacturing or development, working with equipment and calibration.
• 2+ years of experience working in a FDA regulated environment (medical devices)
• Experience with Balloon Catheters and Balloon Catheter Equipment is preferred
• Experience and understanding of electronics/electrical systems is preferred
• Understanding medical device manufacturing and medical device manufacturing environment is preferred
• Experience in implementing an electronic/automated calibration management system is desired
• Must be able to read technical diagrams, schematics, blueprints, and equipment manuals
• Strong technical writing skills
• Must be able to effectively communicate with all levels of management and organizations
• Must be proactive, self-motivated, and work independently with minimal supervision
• Ability to work in a fast-paced environment, managing multiple priorities
• Must be able to work in a cleanroom
• Employee may be required to occasionally lift objects up to 25 lbs.
• Must be willing to travel up to 10% of the time