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Job Description:

Summary of Role:

Under the direction of Engineering manager, the Calibration Engineer will:

·        Be responsible for the calibration system ensuring calibration compliance of equipment as well maintains and improves status of equipment and components key to the manufacture and measurement of medical and other devices

·        Performs the calibration duties, maintaining the department's calibration objectives with zero over dues and provides support to manufacturing, operations, and facilities.

·        Support equipment maintenance, problem solving and continuous improvement

Key Responsibilities:

·        Responsible for guaranteeing all asset’s calibration in a timely, compliant, efficient and consistent manner according to company calibration specifications, guidelines and procedures.

o   Develop and maintain master schedule of calibration to ensure minimum impact on the continuity of daily operations.

o   Ensure that all calibration work orders are arranged and executed in order of priority, recorded in a timely manner by internal personnel or external suppliers in accordance with current procedures.

o   Judge and review the gages status based on the calibration result, maintain and label the different calibration status for all gages.

o   Ensure non-conforming gages and overdue gages are segregated per requirements.

o   Performs calibration procedures correctly by using the applicable calibration standards appropriately.

o   Responsible for maintaining calibration records in Maximo system in a timely and compliant manner.

o   Calibration and qualification of new equipment and input in calibration system.

·        Responsible for maintaining calibration system

o   Maintain local procedures & templates for calibration, ensure all disposition and changes to calibration are made following procedures.

o   Analyze the data from calibration activities, establish and verify the calibration intervals to ensure robust and reliable calibration system.

o   Develop in-house calibration capability.

o   Support and participate in projects/initiatives and develop new calibration methods.

o   Manage spare parts inventory for calibration gages, ensuring that necessary components are readily available for repairs or external calibration.

o   Ensure that the new measuring instruments meet the requirements when implemented in the calibration system.

o   Support quality audits to ensure that calibration audits are always ready

·        Support equipment maintenance, engages in developing and implement equipment PMs to ensure uninterrupted production consistent with established standards.

·        Support problem solving, includes problem definition, root cause analysis, efficiency or productivity improvement, and problem resolution.

·      Identifies improvement options for the calibration system, assist with the implementation of improvements in calibration and engineering processes.

·        Generates calibration related non-conformances (NC) according to local procedures. Support NCs & CAPAs related to calibration process.

·        Follow all company safety policies and other safety precautions within the work area.

·        Follow J&J Records Management Policies for Convenience Information, Records Retention Schedules, Training.

·        Follow GMP requirements.

·        Work with the team to ensure all aspects of the business remain compliant and, in an audit, ready state.

·        Responsible for communicating business-related issues or opportunities to the next management level

·        Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

·        Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

·        Performs other duties assigned as needed

Qualifications/Experience

·        Bachelor’s degree in engineering preferred, Mechanical, Electrical, Electromechanical, Electronics, Metrology, Instrumentalist majors preferred and 4 to 6 years of experience in related fields preferred.

·        3-5 years’ experience in calibration. Knowledge of calibration and metrology required.

·        3-5 years’ experience in the Medical Device and/or pharmaceutical industry or medical field. Knowledge of GMP/ ISO 13485 preferred.

·        Bilingual: Fluency in English, Strong written and oral communication in English required. Second language Dutch preferred

·        Knowledge of information systems including but not limited to Enterprise Resource Planning (ERP), Maximo, Quality Systems & Documentation Control Systems is preferred.

·        Capable to interpret the vendor maintenance/calibration/qualification reports to verify the effectiveness of the vendor’s work and adopt the outcomes into the process.

·        Troubleshooting and problem solving.

·        Knowledge of word processing, spreadsheet analysis, data management.

·        Proper communication skills; making complex issues easy for others to understand when acting as a core team member in projects.

·        Ability to work cooperatively with internal and external stakeholders

·        Ability to build strong working partnerships, trust and credibility at all levels

·        Organizational, collaboration, communication and leadership skills

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.