QA Executive

People Pathfinders; Sungai Petani; On-site; MYR 40,000 - 60,000; Full time

Job summary

A medical device manufacturing company in Sungai Petani is looking for a QA Executive to ensure compliance with quality standards and manage regulatory submissions. The ideal candidate will have a Bachelor’s degree and at least 1 year of experience in a related field. Strong communication skills and the ability to work under pressure are essential for this role.

Qualifications

• Minimum 1 year working experience in a related field.
• Knowledge of ISO 13485, FDA 21 CFR 820, EU MDR is an advantage.
• Familiarity with latex technology and risk management.

Responsibilities

• Ensure compliance with quality management system meeting ISO13485 standard.
• Coordinate regulatory submissions for product registration.
• Organize and manage Quality Assurance department.

Skills

Team player

Good communication skills

Ability to work under pressure

Education

Bachelor’s degree in Science Chemistry, Polymer Science or related field

Job description

Overview

Our client is a manufacturer of high-quality medical devices specializing in latex and latex-free nasopharyngeal airways, breathing bags, test lungs, racine connectors and other rubber-based products and medical devices.

Reporting to the QA Manager, the QA Executive is responsible to ensure implementation of quality management system and regulatory submission for product registration. The role will be based in Sungai Petani.

Responsibilities

• Ensuring implementation and compliance with the requirement of documented quality management system that meets ISO13485 standard and other regulatory standard as applicable
• Coordinating in preparation of different types of regulatory submission to competent authorities for product registration
• Organizing and managing Quality Assurance department and ensure required training is carried out and availability of resources
• To lead and coordinate in quality audit conducted by internal or external bodies
• Document and record control, risk management, post market surveillance, Corrective Action and Preventive Action (CAPA) management, change control, supplier quality, manufacturing quality, calibration, and data analysis
• Authorise COA, COC or COI and other relevant record for product release
• Analysing data to track quality system performance with respect to quality objective and update to management
• Arrange sample for routine sterilization dose audit and obtain approval on dose audit report
• Understand concepts of product quality including performance, patient impact, manufacturing defects and labelling
• Resolve issues with engineering, production, customer service and sales in regards of product design, specifications, materials, tooling and production operations affecting quality
• Participate in quality improvement for continual improvement in quality system, product and service
• Prepare, review and revise procedure, technical report and other document as per QA documentation requirement

Qualifications

• Bachelor’s degree in related field particularly Science Chemistry, Polymer Science and other science related field
• Minimum 1 year working experience in a related field
• Team player, willing to learn and possess good communication skills, both written and oral
• Ability to work as scheduled plan and work under pressure in tight timeline
• Knowledge in latex technology, ISO 13485, FDA 21 CFR 820, EU MDR, FMEA, risk management, CAPA and root cause analysis is an added advantage.