Senior/Quality Engineer (QE, CQE, PQE)

ETI (M) SDN. BHD.; Seberang Perai; Sur place; MYR 60 000 - 90 000; Plein temps

Résumé du poste

ETI (M) SDN. BHD. seeks a Quality Assurance professional to establish, maintain and control processes in a medical manufacturing setting in Penang. You will partner with customers on quality plans, lead FAI reporting, and support audits while driving continuous improvement.

The role requires 2–3 years of QA experience in medical manufacturing, with familiarity in ISO9001/13485, IATF16949, SPC, FMEA, PPAP, APQP, Control Plan, and CAPA oversight.

Qualifications

• 2–3 years working experience in manufacturing quality assurance in Medical industry.
• Familiar with ISO9001, ISO13485, ISO14001, ISO45001, IATF16949.
• Experience in quality analysis, problem solving, and project management and customer audits.
• Experience in SPC, FMEA, PPAP, APQP, Control Plan, IQ, OQ, PQ, and MSA.
• Able to work independently with minimal supervision and show leadership.

Responsabilités

• Set and maintain quality plans with customers and ensure compliance.
• Lead and coordinate FAI reporting and customer audits at site.
• Drive continuous improvement on yield and quality metrics.
• Provide supervision to QA operators, technicians and inspectors.
• Guide engineers and technicians in responding to customer feedback and CAPA.

Connaissances

Quality assurance

Problem solving

Project management

Leadership

Customer interface

Outils

SPC

FMEA

PPAP

APQP

Control Plan

IQ/OQ/PQ

MSA

CNC Turning/Milling

Cold Heading

Description du poste

Process Establishment, Maintenance and Control

• Setting agreed clear requirement with customer through quality plan
• Leading and coordinating FAI report

Compliance of customer requirements, industry standard and safety at workplace

• Primary interface with customers on quality related matter
• Lead activities to improve yield at customer incoming and reduce RMAs
• Lead, participate and support regulatory and customer audits at site

Drive Proactive Continuous Improvement on Yield & Quality Metrics

• Ensure effectiveness of pFMEA
• Work with suppliers on incoming material's quality
• Conduct audit
• Driving the cross-functional team to deliver continual improvement activities for internal processes deliverables

Build and Embed Quality Awareness in Operations

• Ensure effectiveness of training and inspections
• Educate operators and production associations on quality/compliance and procedure

Provide Supervision to QA Supervisors/Inspectors/Technicians

• Supervise QA operators/group leaders/technicians in ongoing quality improvement activities

Provide Technical Guidance & Communications to Engineers/Technicians

• Lead or guide engineers to respond effectively to customers' feedbacks/CAPA, follow up with quality metrics set in quality plan
• Prepare Quality Operations Review
• May perform other duties and responsibilities as assigned.

Job Requirements

• 2-3 years working experience in manufacturing quality assurance in Medical industry.
• Familiar with ISO9001, ISO14001, ISO45001, ISO13485, IATF16949
• Experience in quality analysis, problem solving, and project management and customer audit
• Experience in SPC, FMEA, PPAP, APQP, Control Plan, IQ, OQ, PQ, and MSA
• Familiar with CNC-Turning and Milling, Cold Heading, Stamping, Screw and Die-Cut process
• Working independently and with minimum supervisions
• Show strong leadership and self-driven motivation to achieve excellent result
• Able to speak, read and write Chinese due to customer and counterpart from China