Measurement Calibration Specialist

The Calibration Expert 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, measuring 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.

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 departmental/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.

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

• 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.

Note: This job description is subject to change based on business needs and requirements.