Receiving Technician - S4

Boston Scientific; Penang; Presencial; MYR 50.220 - 72.540; Jornada completa

Descripción de la vacante

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.

Formación

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

Responsabilidades

• 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.

Conocimientos

IQC processes

Root cause analysis

Independent work

Documentation

CAPA

Educación

Diploma in Engineering/Science/Biomedical/Quality

Herramientas

Smartscope

Instron

Calipers

Micrometers

Gauges

Descripción del empleo

Purpose Statement

The Receiving Technician is responsible for providing an independent and unbiased evaluation of incoming materials to ensure they meet quality specifications and regulatory requirements before being released for production. This role supports supplier quality by conducting inspections, managing non-conforming materials, maintaining quality documentation, and contributing to continuous quality improvement.

Minimum Requirements

• Diploma in Engineering, Science, Biomedical, Quality, or a related field.
• Minimum 4 years of experience in Incoming Quality Control (IQC), Receiving Inspection, or a manufacturing/medical device environment.

Key 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.

Required Skills & Knowledge

• Proficient in using inspection and measurement equipment such as Smartscope, Instron, calipers, micrometers, gauges, and other precision measuring instruments.
• Strong understanding of Incoming Quality Control (IQC) processes.
• Knowledge of GMP, ISO 13485, FDA 21 CFR Part 820, Good Documentation Practices (GDP), CAPA, Non-Conformance processes, Sampling Plans, and AQL methodologies.
• Strong problem-solving and root cause analysis skills.
• Able to work independently with minimal supervision.
• Good communication, documentation, and report-writing skills.
• Experience in the medical device manufacturing industry is highly preferred.