Calibration Engineer

Boston Scientific Gruppe; Penang; On-site; MYR 40,000 - 60,000; Full time

Job summary

Boston Scientific seeks a Calibration SME in Penang, Malaysia. This role involves maintaining the Calibration Management System, ensuring compliance with regulations, and managing calibration processes. Candidates should have a degree in a related field and at least three years of experience, preferably in the medical device industry.

Qualifications

• Minimum 3 years experience in manufacturing, preferably in medical devices.
• Knowledge of standards such as ISO/IEC 17025.
• Ability to coordinate with quality assurance and engineering departments.

Responsibilities

• Manage Calibration Management System (CMS) and work orders.
• Track equipment calibration status and compliance.
• Prepare calibration reports/metrics and manage budgets.

Skills

Technical expertise in calibration principles

Problem-solving skills

Attention to detail

Strong communication skills

Understanding of process engineering

Education

Degree in Electrical and Electronic or Electromechanical Engineering

Job description

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• Calibration SME and Maintains the Calibration Management System (CMS).
• Create and maintain calibration work orders.
• Track and trend equipment due and overdue.
• Maintains calibration investigation forms and works closely with equipment owners and coordinators to ensure prompt closure.
• Serves as a point of contact for internal customers (Value Streams, New Product and Project teams as necessary on calibration related requirements).
• Creates and Maintains calibration records, logs and files.
• Prepares, maintains and distributes calibration reports/metrics.
• Gathers and prepare data in preparation for project needs.
• Provides input to Equipment Suitability & Selection as needed from a Calibration management perspective.
• Manages Calibration spend in line with approved budgets.
• Manages Training Compliance in line with Site goals/targets for Calibration Team.
• Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures & system requirements.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
• Develops work schedules for Calibration Team by assessing priorities, workload and resource management.
• Manages all Purchase Orders & invoicing for external Calibration suppliers & customers.
• Leads by example by observing and complying with all safety rules and quality regulations, including QSR and ISO Standards.
• Troubleshoots and solves problems requiring interpretation of procedures and practices. Creates or updates documentation as needed to resolve issues.
• Creates or modifies equipment, schedule, and work records within the calibration management system.
• Applies knowledge of technical concepts, from basic to complex, towards the resolution of manufacturing and/or research and development calibration tasks.
  

Requirements

• Minimum Degree in Electrical and Electronic or Electromechanical Engineering, or related field.
• At least 3 years of working experience in manufacturing environment. Prior experience in the medical device industry is preferred.
• Required skills:
  
  • Technical expertise in calibration principles, measurement techniques, and instrumentation.
  • Problem-solving skills to diagnose and resolve calibration issues efficiently.
  • Attention to detail to ensure precision in measurements and compliance with regulations.
  • Knowledge of standards such as ISO/IEC 17025 and other industry-specific calibration requirements.
  • Strong communication skills to document procedures and collaborate with teams.
  • Ability to work in a team and coordinate with quality assurance and engineering departments.
  • Understanding of process engineering to optimize calibration methods

About Us

As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

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