Senior Quality Engineer – Medical Devices

Masimo Medical Technologies (Malaysia) Sdn. Bhd.; Pasir Gudang; On-site; MYR 90,000 - 140,000; Full time

Job summary

Masimo Medical Technologies (Malaysia) Sdn. Bhd. is seeking a Quality Engineer to provide technical input across the product manufacturing process.

You will manage multiple projects, ensuring devices meet defined production quality standards and supporting process validations, inspections and tests. The role requires five to seven years in quality engineering within device manufacturing, ISO 13485 experience, and strong problem-solving and project management skills.

Qualifications

• Five to seven years of experience in quality engineering in a device manufacturing environment.
• Direct experience with ISO 13485.
• Root Cause Investigation, failure analysis, and developing robust corrective and preventive actions.
• Direct experience in quality system audits.
• Ability to travel internationally occasionally.
• Proficiency with Microsoft Office applications.
• Strong communication, documentation, problem solving and leadership/management skills.
• Strong Project Management experience.
• Independent worker, who is flexible and adaptable.

Responsibilities

• Assist Quality Manager on the quality assurance and product quality.
• Supports product manufacturing through the application of quality engineering tools.
• Assure conformance of systems and processes during manufacture, and quality control operations with respect to internal procedures, FDA CFR 21 820, ISO 13485, CMDR and other standards.
• Leads and participates in problem solving activities related to manufacture and inspection and test, including NCR and supplier issues.
• Communicates significant issues or developments during quality inspection activities and provides plans and recommendations to the team and management for resolution.
• Leads and/or participates in IQ/OQ and PQ activities, test sample size selections, method validations, Gage R&R studies and risk management.
• Develops and manages programs that monitor or regulate manufacturing and inspection activities using statistical tools.
• Supports quality compliance process including data generation for NCR, RI and in-process inspections.
• Performs any reasonable task assigned by manager.
• Reports effectiveness of the quality management system to Masimo’s management representative.

Skills

Quality engineering

Root cause analysis

Project management

Strong communication

Independent worker

Education

B.S. in Science or Engineering

MS in Science or Engineering or MBA (preferred)

Tools

Microsoft Office

Job description

Masimo Medical Technologies (Malaysia) Sdn. Bhd. is seeking a Quality Engineer to provide technical input across the product manufacturing process.

You will manage multiple projects, ensuring devices meet defined production quality standards and supporting process validations, inspections and tests. The role requires five to seven years in quality engineering within device manufacturing, ISO 13485 experience, and strong problem-solving and project management skills.