Full Time Engineer - Senior Engineer, Quality Jobs, Salary up to MYR 7,000 in Munivac Johor - Maukerja

Job Summary:

As a Engineer, Quality, you will be responsible for drive and support an effective quality management system for mass volume manufacturing from new program introduction to sustaining manufacturing which meets the requirements of quality management standards such as ISO9001 and/or ISO13485, quality system regulations, relevant products regulatory and customer requirements.

Key Responsibilities:

• Support the Quality Manager in managing daily quality assurance activity to ensure the out-of-factory product quality

Undertake continuous improvements projects and/or assignments dedicated by the management

• Support NPI, risk management, validation qualification, production part approval process activities and its documentation to meet predetermined requirements
• Establish strategic inspection plan enhancement implementation & responsible for generating quality guides or documentation to train quality technicians and/or production operators
• Optimize Quality Inspection Productivity and Efficiency for sustaining MP Projects.
• Ensure timely review & proper maintenance of device history records (DHR) in accordance with the requirements of ISO13485, customer & relevant regulatory requirements
• Engage customers and/or suppliers on matters relating to product quality issues
• Drive continuous improvements activity through 8-D discipline, CAPA or equivalent tools
• Support internal, 3rd party or customer quality system and/or process audits
• Drive internal MRB meetings for proper disposition and control of non-conforming materials
• Minimize Wastage & Resource Consumption for all Quality related activities / inspections through strategic adjustments to QC Inspection Plan.
• Support internal ECR meetings for proper change control process
• Responsible for data collection and reporting quality performance in management and customer reviews.

Qualifications:

• Diploma or Basic Degree in Quality Assurance, Science, Mechanical Engineering or equivalent.
• Minimum 2 years relevant quality function work experience in a manufacturing environment.
• Good understanding of quality management system requirements (e.g. ISO 9001 and ISO 13485, or IATF 16949) and/or 21CFR Part 820 QSR, is desirable.
• Able to work independently and has good communication skills
• Familiar with statistical analysis & applications using Minitab software
• Familiar with risk management process tools such as PFMEA
• Familiarity with computer-aided design (CAD) software and quality management systems (QMS) is advantageous.

Job Types: Full-time, Permanent

Pay: RM4,000.00 - RM7,000.00 per month

Benefits:

• Dental insurance
• Free parking
• Health insurance
• Opportunities for promotion

Work Location: In person