Measurement Expert

Job Title: Calibration Engineer

The Calibration Engineer is a key role responsible for leading and maintaining the Plant Procedure for Calibration of Measuring FUE and Software Validation, ensuring compliance with QMS structure.

• Maintain or update Facility Equipment Log (Calibration Master List and Calibration Recall List) of all inspection, measuring and test equipment.
• Coordinate and manage the calibration recall process and impound all inspection, measurement and test equipment that have expired calibration status.
• Coordinate with approved calibration service provider or internal facilities group for calibration of inspection, measuring and test equipment. Review and approve the calibration records and certificates into the Agile system.
• Supply Recall List to all affected departments within the facility on a monthly basis or other specified frequency.
• Maintain calibration records in accordance with Control of Quality Records.
• Support in all 1st party, 2nd party and 3rd party audits.
• Organize and perform internal audit of plant-wide measuring and monitoring devices requiring calibration with reference to the Calibration Master List.
• Actively participate and support in customer audits where applicable and necessary.
• Manage, coordinate and actively participate in all regulatory body audits and statutory organization inspections.
• Support in consolidating and updating calibration records and data for Management Review per QMS requirements.
• Conduct and actively participate in risk management matters and documentation that are associated to QMS, EMS, DCC and CAPA processes and systems.
• Oversee the responses, resolutions and timely closure of assigned CAR, PAR and SCAR.
• Manage and update Calibration associated procedures, work instructions and templates and quality records.
• Conduct training on Calibration related procedures, work instructions and templates to peers and subordinates.

Key Responsibilities:

• FUE Qualification, Software Validation and Process Validation
• Write/ Document down Validation Assessment (FUE Qualification) and Software Validation Assessment (Software Validation)
• Prepare the IQ, OQ, PQ, VCR Report and all associated Validation documents
• Maintain the Master Validation Plan (MVP) and Master Validation Report (MVR)
• Review the existing MVR and Software List to ensure compliance to the validation procedures
• Organize and perform internal audit of the Plant MVP and MVR
• Drive Quality mindset, awareness and culture throughout the company
• Ensure compliance and implementation of quality assurance standards and procedures
• Collaborate with other departments/sections by providing technical considerations and solutions to peers and stakeholders on department/sectional validation matters
• Assist in all software integration and automation projects
• Lead/participate in continuous improvement projects
• Assist and support the immediate superior and Plant appointed Management Representative (MR) to drive continuous improvement initiatives and strategies within the department/section through CAPA, Change Control, Lean Six Sigma (LSS), Kaizen and Mini-company approaches

About Us

We are seeking an experienced and skilled professional to join our team as a Calibration Engineer. The ideal candidate will have strong knowledge of manufacturing processes, ESD control and international industrial standards.

Requirements:

• Minimum Degree or Diploma in Electronics/Mechanical/Manufacturing Engineering or equivalent
• Minimum 2 years experience, preferably in a manufacturing environment
• Project management and leadership capabilities
• Experience in managing calibration and validation systems is an added advantage
• Knowledge of manufacturing processes and ESD control or in the related field is preferred
• Knowledge of manufacturing in PCBA environment or in related field is preferred
• Knowledge of international industrial standard is required (ISO 9001, ISO 14001, ISO 13485, FDA CFR Part 820, FDA CFR Part 11, JPAL MHLW Ordinance Number 169, MDSAP)
• Knowledge in Quality Tools, problem-solving skills is preferred
• Experience in operating Agile PQM and PLM and Oracle is preferred
• Proficient in Microsoft Office, Google Suite and Google Data Studio applications
• Knowledge and experience in Lean Manufacturing and 6-Sigma Management is preferred
• Trained in FMEA and Technical Writing is an added advantage
• Equipped with soft skills in managing people, leadership qualities, analytical and logical thinking is preferred