Job Responsibilities:
- Lead and responsible for maintaining Plant Procedure for Calibration of Measuring FUE and Software Validation, that complies with QMS structure.
- Maintain or updating Facility Equipment Log (Calibration Master List and Calibration Recall List) of all inspection, measuring and test equipment.
- Coordinating and mange the calibration recall process and impounding all inspection, measurement and test equipment that have expired calibration status.
- Coordinating 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.
- Supplying Recall List to all affected departments within the facility on monthly basis or other specified frequency.
- Maintaining 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 template and quality records.
- Conduct training on Calibration related procedures, work instructions and template to peers and subordinates.
- Others roles, responsibilities and duties as assigned in Corporate and Plant management system documentations, such as in Plant adopted procedures and work instructions.
- Assist and responsible for maintaining Plant procedures for FUE Qualification, Software Validation and Process Validation, that complies with QMS requirements.
- Write/ Document down Validation Assessment (FUE Qualification) and Software Validation Assessment (Software Validation), IQ, OQ and PQ Protocol and follow through the protocol execution.
- Prepare the IQ, OQ, PQ, VCR Report and all associated Validation documents, review with the Process Owner and route for approval.
- 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 thorough 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.
- Other duties as assigned.
Job 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 will be an added advantage,
- Knowledge of manufacturing processes and ESD control or in the related field preferred.
- Knowledge of manufacturing in PCBA environment or in related field 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 will be an added advantage.
- Equipped with soft skills in managing people, leadership qualities, analytical and logical thinking is preferred.
