QC Engineer

QC Engineer - OEM Division

Requirement :

• Bachelor's Degree in Engineering or any related field.
• Minimum 3 years' experience in the manufacturing industry.
• At least 2 years' experience in quality or process-related functions is an advantage.
• Proficient in FMEA, risk management, control plans, and preparation of work instructions.
• Skilled in problem-solving and data analysis using tools such as the 7QC tools, Non-Conformance Reports, and Why-Why Analysis.
• Experienced in preparing and implementing SOPs, including document and record control, in line with ISO requirements.
• Knowledge of ISO 13485 and other relevant regulated medical device standards is an advantage.
• Strong analytical and decision-making skills with the ability to identify and resolve issues effectively.

Scope of Duties :

Process, Yield Monitoring & Improvement

Establish all required work procedures and records etc for the OEM project with related team members following ISO 13485 as well as FDA and customer requirements.

2. NC & CAPA

3. Risk Management for QC processes

4. 4M Change Request

5. Others

Benefits include :

Job Types : Full-time, Permanent

Pay : RM3, RM5,000.00 per month

Benefits :

Ability to commute / relocate :

Application Question(s) :

Experience :

Work Location : In person