Diploma/Degree in Quality Management, Mechanical Engineering,
Manufacturing Engineering or related field. Minimum 2 years of experience in ISO 9001 Quality Management System; experience in ISO 13485 is an added advantage.
Experience in handling customer complaints, quality investigations and implementing corrective and preventive actions (CAPA). Familiar with quality tools such as 8D Report, Root Cause Analysis (RCA), FMEA, SPC and 5 Why Analysis.
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Minimum SPM/Diploma in Engineering or related field.
Minimum 2 years of experience in quality inspection within a precision machining or manufacturing environment. Knowledge and hands-on experience in operating VMM and CMM. Able to read engineering drawings, GD&T and dimensioning requirements.
Familiar with measuring equipment such as Vernier Caliper, Micrometer, Height Gauge and Pin Gauge.
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Bachelor’s degree in an Engineering discipline or related field of study. 2+ years of experience in Quality, QA or related medical device experience. Knowledgeable in Quality System Regulations, Medical Device Regulations, ISO 13485 Quality Standards and FDA 21 CFR Part 820 and FDA 21 CFR Part 11
Bachelor’s degree in an Engineering discipline or related field of study. 2+ years of experience in Quality, QA or related medical device experience. Knowledgeable in Quality System Regulations, Medical Device Regulations, ISO 13485 Quality Standards and FDA 21 CFR Part 820 and FDA 21 CFR Part 11
Semiconductor Manufacturing
Quality Assurance
Defect Tracking
Statistical Process Control
Root Cause Analysis
Problem Solving
Attention to Detail
Communication Skills
Team Collaboration
Documentation