Calibration Engineer

4 weeks ago

Hyderabad, Telangana, India Tek Support Full time

Job Title: Calibration Engineer

Location: Hyderabad, India

Experience: 10+ Years

Industry: Medical Devices / Pharmaceuticals

Job Overview:

We are seeking a senior Calibration Engineer with 10+ years of experience in regulated environments such as medical devices, pharmaceuticals, or diagnostics. The ideal candidate will not only be technically proficient in calibration and metrology but also capable of training and mentoring engineers and technicians on calibration best practices, quality system compliance, and equipment management.

This role requires deep hands-on expertise with electrical and mechanical calibration systems, along with strong knowledge of regulatory standards (FDA 21 CFR Part 820, ISO 13485, ANSI/NCSL Z540.3, and ISO 17025). The successful candidate will design and deliver structured training programs while overseeing calibration activities across production, R&D, and testing environments.

Key Responsibilities:

  • Lead calibration of medical and lab equipment, ensuring NIST-traceable accuracy across pressure, flow, temperature, force, and electronic measurement devices.
  • Develop and deliver structured training modules to upskill calibration technicians and junior engineers on instrumentation, metrology, and compliance.
  • Draft and maintain calibration procedures, SOPs, and related quality documentation.
  • Ensure regulatory compliance with ISO 13485, FDA QSR, and internal audit readiness.
  • Oversee calibration schedules, documentation, and asset control using CMMS tools (e.g., Blue Mountain, ProCal).
  • Perform statistical analysis (MSA, uncertainty budgets) and root cause investigations for out-of-tolerance (OOT) events.
  • Provide hands-on support for validation/verification activities (IQ/OQ/PQ) and support regulatory inspections.

Key Skills & Tools:

  • Strong proficiency with calibration instruments: Fluke calibrators, signal generators, oscilloscope, pressure calibrators, multimeters, temperature baths.
  • Deep understanding of electromechanical systems, loop calibration, instrumentation, and automation control.
  • Familiarity with GAMP 5, risk-based validation, and good documentation practices.
  • Knowledge of safety standards such as NFPA 70E, NEC, and IEC 61010.
  • Skilled in CMMS tools and documentation systems.

Qualifications:

  • Bachelor's or Master's degree in Electrical, Electronics, Biomedical, or Instrumentation Engineering.
  • 10+ years in calibration engineering within the medical device or life sciences industry.
  • Experience in a trainer or mentoring capacity is essential.
  • ASQ-CCT or ISO 17025 internal auditor certification is a plus.
  • Strong communication skills to support cross-functional training and documentation.

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