Medical Device QC Inspector - Quality Assurance

Hochuen Medical Sdn Bhd; Johor Bahru; On-site; MYR 39,000 - 56,000; Full time

Job summary

Jora Malaysia is seeking a QC Inspector to inspect, measure and test parts/products to ensure they meet quality standards and customer requirements. This role is attached to the Quality Department and focuses on ensuring product conformance throughout the production process.

Responsibilities include IQC/FAI/IPQC/OQC inspections, maintaining inspection records for ISO audits, operating QC equipment, collaborating with production to address defects, and supporting ISO documentation and audits,

Qualifications

• SPM or equivalent.
• Minimum of 1 year of experience in quality control manufacturing, preferably in medical device, pharmaceutical or biotechnology industries.
• Basic knowledge of quality standards, for example, ISO 13485.
• Proficiency in using quality control tools and measurement devices, such as calipers, height gauge, image measuring instrument.
• Strong documentation skills, attention to details and ability in analysis and problem-solving.
• Able to communicate in English and Mandarin is an added advantage.

Responsibilities

• Conduct IQC/FAI/IPQC/OQC inspection and testing of incoming material, in-process product and finished goods to verify its conformance with product specifications.
• Maintain accurate and detailed records of inspection of production line (incoming material, in-process and finished goods) and testing data for ISO audit purposes.
• Maintain and operate QC inspection and testing equipment.
• Collaborate with production team to solve quality issues, properly handling of non-conforming or suspected products, report the non-conforming or any defects/deviation to quality supervisor.
• Assist in preparation and implementation of ISO document, SIP, SOP, records and training material ,refer to standard & limited sample as needed.
• Assist in preparation of internal and external audit, ensuring all quality checking documents/records are in compliance with ISO13485.
• Support the investigation of customer complaints, helping to identify root cause and implement corrective actions as necessary.

Skills

Quality control

Documentation

Analysis

Problem solving

Communication in English

Mandarin (optional)

Education

SPM or equivalent

Tools

Calipers

Height gauge

Image measuring instrument

Job description

Jora Malaysia is seeking a QC Inspector to inspect, measure and test parts/products to ensure they meet quality standards and customer requirements. This role is attached to the Quality Department and focuses on ensuring product conformance throughout the production process.

Responsibilities include IQC/FAI/IPQC/OQC inspections, maintaining inspection records for ISO audits, operating QC equipment, collaborating with production to address defects, and supporting ISO documentation and audits,