Engineer I (QA)

Job description

Job Description

Engineer I (QA)

Job Responsibilities

• Lead and responsible for maintaining Plant procedures, work instructions and forms that are associated with customers’ products, processes, and supplier management that complies with the QMS structure and customers’ requirements.

• Oversee the creation, review and management of all customers’ quality control plans with reference to customer specifications, requirements and expectations, including New Product Introduction (NPI), First Article Inspection (FAI), Failure Analysis (FA) and its associated inspection and process control requirements and operations.

• Responsible for maintaining the need for tests, assessments, qualifications and validations of environment, tools, equipment, machineries, processes, systems and products within the manufacturing process, including documented records to support NPI, in order to remain in qualified and/or validated state.

• Participate proactively as a contributor to the Customer Focus Team (CFT) on product and process quality matters.

• Support Product Quality Engineering on product quality issues, including submission of regular quality reports to meet customer expectations and to support the closure of CAPA and CCN.

• Support Supplier Quality Engineering on supplier quality issues, including consolidation of quality records to support the closure of SCAR.

• Provide advice and guide Quality personnel on process control specifications and requirements, quality control plans, process FMEA, product RMA, rework, repair, purge, quality alert notifications, temporary deviations, non-conformance parts/components/materials reporting, and all associated queries in relation with the QMS and/or EMS, customer’s specifications, requirements and expectations.

• 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 the manufacturing process.

• Monitor, coordinate and manage all inspection, measurement and test equipment due for calibration within the manufacturing process.

• Manage and enforce counterfeit supplies avoidance measures and controls to ensure compliance to Corporate policies and Plant QMS requirements.

• Conduct and proactively participate in risk management matters and documentations that are associated to QMS, EMS, DCC, CCN and CAPA processes and systems.

• Conduct reinforce training on Plant procedures, work instructions and forms that are associated with the QMS and/or EMS, customers’ product and process specifications, requirements and expectations, to peers and subordinates.

• Interface with manufacturing and inter-sectional/inter-departmental personnel to drive for continual improvement in product and process quality.

• Participate proactively as a contributor 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.

• Participate proactively as a contributor in Supplier Quality performance and work with supplier on incoming parts/components/materials quality matters for continual improvement.

Participate proactively as a contributor 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.

• Participate proactively as a contributor in reviewing and approving NCMR’s with “Use-As-Is” depositions to ensure parts/components/materials in the Material Review Board (MRB) have been appropriately classified and qualified.

• Drive to control the numbers, costs, and all deliverables related to non-conforming parts/components/materials residing in the MRB with appropriate dispositions, and clear deadlines to prevent delays, aging and uncertainties.

• Oversee the responses, reporting and timely submissions of Plant and Corporate driven performance reports in areas associated with the PQE 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.

• Any other duties as assigned.

Job Requirements:

• Degree or Diploma in Electronics / Mechanical / Manufacturing Engineering or equivalent.

• Minimum 5 years experience in electronics manufacturing environment as QA Engineer or in related field, especially in IMS industry is preferred.

• Experience in incoming quality assurance and its daily operational deliverables will be an added advantage.

• Project Management and Leadership capabilities.

• 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.

• 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.

• Proficient in Microsoft Office applications (i.e. Excel, Words and PowerPoint), Google Looker Studio.

Required Skill Profession

Engineers