Receiving Inspector – IQC & GMP for Medical Devices

Boston Scientific; Penang; On-site; MYR 50,220 - 72,540; Full time

Job summary

The Receiving Technician at Boston Scientific in Penang, Malaysia, evaluates incoming materials to ensure they meet quality specifications and regulatory requirements before release to production.

Responsibilities include performing IQC inspections, handling non-conforming materials, maintaining QA documentation, supporting CAPA activities, and ensuring GMP, ISO 13485, FDA Quality System Regulations, and GDP compliance.

Qualifications

• Diploma in Engineering, Science, Biomedical, Quality, or related field.
• Minimum 4 years' experience in IQC or receiving inspection in a manufacturing/medical device environment.

Responsibilities

• Perform incoming inspection of raw materials, components, and purchased parts using approved inspection methods and measuring equipment.
• Verify inspection results and ensure materials comply with drawings, specifications, and quality standards.
• Identify, document, and investigate non-conforming materials, and support root cause analysis and CAPA activities.
• Maintain accurate inspection records and QA documentation in accordance with company procedures.
• Support supplier quality activities, audits, material qualifications, and continuous improvement initiatives.
• Handle discrepant materials according to established procedures and maintain quarantine/MRB inventory when required.
• Ensure compliance with GMP, ISO 13485, FDA Quality System Regulations, and Good Documentation Practices (GDP).
• Provide technical support and guidance on incoming inspection processes as required.

Skills

IQC processes

Root cause analysis

Independent work

Documentation

CAPA

Education

Diploma in Engineering/Science/Biomedical/Quality

Tools

Smartscope

Instron

Calipers

Micrometers

Gauges

Job description

The Receiving Technician at Boston Scientific in Penang, Malaysia, evaluates incoming materials to ensure they meet quality specifications and regulatory requirements before release to production.

Responsibilities include performing IQC inspections, handling non-conforming materials, maintaining QA documentation, supporting CAPA activities, and ensuring GMP, ISO 13485, FDA Quality System Regulations, and GDP compliance.