Engineer I (Calibration)
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, SOP-3-4002-MD
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:
Degree or Diploma in Electronics / Mechanical / Manufacturing Engineering or equivalent.
Minimum 2 years experience in the manufacturing environment as QA Engineer or in related field, especially in IMS industry is preferred.
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.
