Quality Assurance Engineer – Medical Devices & NPI

MeHow Medical (M) Sdn Bhd; Simpang Ampat; On-site; MYR 48,000 - 72,000; Full time

Job summary

MeHow Medical (M) Sdn Bhd in Malaysia seeks a Quality Assurance professional with at least 2 years in manufacturing to ensure product quality and drive continuous improvements. You will work with cross-functional teams on mold evaluations, accept/reject criteria, and regulatory documentation to meet ISO13485 and customer requirements.

The role emphasizes handling customer/supplier quality issues, implementing PPAP, PFMEA, and CAPA, and validating processes with IQ/OQ/PQ.

Qualifications

• Bachelor's degree in engineering or related field with at least 2 years in manufacturing.
• Knowledge of QMS and ISO 13485; medical device experience is a plus.
• Experience in NPI, mold evaluation or injection moulding; lab testing equipment GCMS/LCMS a plus.
• Familiar with 8D, 5 Why, Fishbone, FMEA, Control Plan, SPC, CAPA and PPAP.
• Experience handling customer and supplier quality issues and CAPA actions.

Responsibilities

• Monitor product quality to ensure compliance with specifications and standards.
• Initiate continual improvement based on feedback from customers and suppliers.
• Lead quality assurance activities and documentation to meet ISO/regulatory requirements.
• Collaborate with cross-functional teams during mold evaluation to ensure product compliance.
• Define inspection and testing criteria for products/processes from customer requirements.
• Evaluate customer quality standards, tolerances, and measurement fixtures.
• Prepare acceptance/reject/limit samples for production references.
• Handle customer and supplier complaints and ensure effective resolutions.
• Oversee ECN effectiveness and prepare PPAP documents (PFMEA, Control Plan, SCR, etc.).
• Support process validation (IQ/OQ/PQ) and other duties as assigned.

Skills

Root cause analysis

8D problem solving

FMEA

CAPA

Control plan

SPC

Cross-functional teamwork

Documentation

Quality tools knowledge

Communication skills

Education

Bachelor's degree in Engineering, Quality Management, Manufacturing, or related field

Tools

GCMS

LCMS

Job description

MeHow Medical (M) Sdn Bhd in Malaysia seeks a Quality Assurance professional with at least 2 years in manufacturing to ensure product quality and drive continuous improvements. You will work with cross-functional teams on mold evaluations, accept/reject criteria, and regulatory documentation to meet ISO13485 and customer requirements.

The role emphasizes handling customer/supplier quality issues, implementing PPAP, PFMEA, and CAPA, and validating processes with IQ/OQ/PQ.