Incoming Quality Engineer
2 months ago
Job Responsibilities:Monitor, assess customer returns and work on corrections, corrective and preventive to improve product quality and manufacturing.....
Job Responsibilities:
- Monitor, assess customer returns and work on corrections, corrective and preventive to improve product quality and manufacturing process.
- Monitor, coordinate and manage all inspection, measurement and test equipment maintenance program within IQE and IQA sections.
- Monitor, coordinate and manage all inspection, measurement and test equipment due for calibration within IQE and IQA sections.
- Manage and enforce counterfeit supplies avoidance measures and controls to ensure compliance to Corporate policies and Plant QMS requirements.
- Responsible for maintaining the need for qualification and validation of environment, equipment/tool/machine within IQE and IQA locations to remain in qualified and/or validated state.
- Conduct and actively participate in risk management matters and documentations that are associated to QMS, EMS, DCC and CAPA processes and systems.
- Conduct training on Plant procedure for Incoming Quality and all its associated procedures, work instructions and forms to peers and subordinates.
- Interface with manufacturing personnel to drive for continual improvement in product quality.
- Support in all 1st party, 2nd party and 3rd party audits.
- Organize and actively participate in internal audits (such as manufacturing process and ESD audits) where applicable and necessary.
- Actively participate and support in customer and supplier audits where applicable and necessary.
- Manage, coordinate and actively participate in all regulatory body audits and statutory organization inspections.
- Support in Supplier Quality performance and work with supplier on incoming part/component/material quality matters for continual improvement.
- Support in managing suppliers by performing system and compliance audits on suppliers during supplier selection, qualification/evaluation and re-evaluation to ensure compliance to Regulatory, Corporate and Plant QMS requirements.
- Support in reviewing and approving NCMR’s with “Use-As-Is” depositions to ensure parts/materials/components in the Material Review Board (MRB) have been appropriately classified and qualified.
- Oversee the responses, reporting and timely submissions of Plant and Corporate driven performance reports in areas associated with the IQA operations and SQE functions.
- Play a key role in enforcing effective communication and social-interaction across all departments/sections whenever necessary.
- Assist, lead and collaborate with other departments/sections on departmental/sectional improvement projects to improve productivity, eliminate operational waste and increase efficiency of work.
- 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 roles, responsibilities and duties as assigned in Corporate and Plant management system documentations, such as in Plant adopted procedures and work instructions.
Job Requirements:
- Minimum Degree or Diploma in Electronics / Mechanical / Manufacturing Engineering or equivalent.
- Minimum 3 years experience in electronics manufacturing environment as QA Engineer or in related field, especially in IMS industry is preferred.
- Knowledge of manufacturing processes and ESD control or in the related field preferred.
- Knowledge of manufacturing in PCBA environment or in related field, and application of associated IPC standards preferred.
- Knowledge of International Industrial standard is required ISO 9001, ISO 14001, ISO 13485,US FDA 21 CFR Part 820, US FDA 21 CFR Part 11, Japan PMDA MHLW Ordinance Number 169, MDSAP
- Knowledge of Quality Tools, problem solving skills is preferred.
- Experience in operating Agile PQM, Agile PLM, Receiving Meastro, Inspection Meastro, SQR, Oracle and MRB is preferred.
- Proficient in Microsoft Office applications (i.e. Excel, Words and PowerPoint), Google Looker Studio.
- Knowledge and experience in Lean Manufacturing and 6-Sigma Management is preferred.
- Trained in FMEA and Technical Writing will be an added advantage.
- Application of Artificial Intelligence (AI) and automation works.
- Equipped with soft skills in managing people, leadership qualities, analytical and logical thinking are preferred.
- Experience in incoming quality assurance and its daily operational deliverables will be an added advantage.
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