Senior Calibration and Validation Specialist

We are seeking a highly skilled Senior Calibration and Validation Specialist to join our team. In this role, you will be responsible for maintaining plant procedures for calibration of measuring FUE and software validation, ensuring compliance with quality management systems (QMS).

• 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, impounding all inspection, measurement, and test equipment that have expired calibration status.
• Coordinate with approved calibration service providers or internal facilities groups for calibration of inspection, measuring, and test equipment, review and approve calibration records and certificates into the Agile system.
• Supply recall lists to affected departments within the facility on a monthly basis or other specified frequencies.
• Maintain calibration records in accordance with control of quality records.
• Support all 1st party, 2nd party, and 3rd party audits.
• Organize and perform internal audits 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 consolidating and updating calibration records and data for management review per QMS requirements.
• Conduct and actively participate in risk management matters and documentation associated with QMS, EMS, DCC, and CAPA processes and systems.
• Oversee 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.
• Other roles, responsibilities, and duties as assigned in corporate and plant management system documentations.

To be successful in this role, you should possess the following skills and qualifications:

• Minimum degree or diploma in electronics, mechanical, or manufacturing engineering or equivalent.
• Minimum 2 years of 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 related fields preferred.
• Knowledge of international industrial standards, including ISO 9001, ISO 14001, ISO 13485, FDA CFR Part 820, FDA CFR Part 11, JPAL MHLW Ordinance Number 169, and MDSAP.
• Knowledge of quality tools and 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 Six-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.

This role offers a comprehensive benefits package, including:

• A competitive salary.
• A range of health insurance options.
• A generous retirement plan.
• Professional development opportunities.
• A supportive and collaborative work environment.

We offer a dynamic and challenging work environment that encourages growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.