Manufacturing Quality Engineer(Plastics Injection-ISO 13485)

Randstad Singapore; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Randstad Singapore is seeking a Quality Engineer for a specialist contract manufacturer in the medical device space. The role focuses on coordinating QA activities, maintaining the QMS documentation, and acting as the QMR to ensure regulatory compliance.

You will drive internal audits, FAI activities, PFMEA for new projects, and collaborate with engineering and suppliers to address quality issues at the source. A mechanical engineering background and ISO13485 knowledge are essential.

Qualifications

• Bachelor's Degree / Diploma in Mechanical Engineering.
• 3+ years of Quality Engineering experience in a high-volume plastics injection or regulated medical device manufacturing environment.
• Deep understanding of ISO 13485 and FDA 21 CFR Part 820.
• Proven experience writing and executing NCRs, CAPAs, deviation reports, and process validations (IQ/OQ/PQ).
• Proficiency in reading engineering drawings/GD&T and using measurement/inspection tools.

Responsibilities

• Plan, coordinate and oversee all Quality Assurance activities in the Company.
• Oversee the Documentation Control function for Quality Management System.
• Act as the Quality Management Representative for the Company.
• Develop and implement plans to collect quality data at in-process, final inspection, test and inspection stations.
• Plan and execute annual Internal Audit to ensure all quality systems and procedures are effectively implemented and auditable at all times.
• Manage first article inspections and sample evaluation activities; partner with engineering and local suppliers to address quality issues at the source. Support design transfers, process validations (IQ/OQ/PQ), and perform PFMEAs for new projects.
• Oversee incoming, in-process, and final End-Of-Line (EOL) testing and inspections.
• Manage first article inspections (FAI), maintain Device History Records (DHR), and perform final quality sign-off for product release.

Skills

Quality Engineering

GD&T reading

NCRs / CAPAs

IQ/OQ/PQ validation

Measurement tools

Education

Bachelor's Degree / Diploma in Mechanical Engineering

Tools

Measurement tools

Job description

My client is a specialized manufacturer in the contract manufacturing space. They are a Singapore based company and with their innovative technology, this is a great brand to join at an exciting time in their development.

about the job

• Plan, coordinate and oversee all Quality Assurance activities in the Company
• Oversee the Documentation Control function for Quality Management System
• Act as the Quality Management Representative for the Company
• Develop and implement plans to collect quality data at in-process, final inspection, test and inspection stations
• Plan and execute annual Internal Audit to ensure all quality systems and procedures are effectively implemented and auditable at all times
• Manage first article inspections and sample evaluation activitiesPartner with engineering and local suppliers to address quality issues at the source. Support design transfers, process validations (IQ/OQ/PQ), and perform PFMEAs for new projects
• Oversee incoming, in-process, and final End-Of-Line (EOL) testing and inspections
• Manage first article inspections (FAI), maintain Device History Records (DHR), and perform final quality sign-off for product release

job requirement

• Bachelor's Degree / Diploma in Mechanical Engineering
• 3+ years of Quality Engineering experience in a high-volume plastics injection or regulated medical device manufacturing environment
• High volume manufacturing environment
• Deep understanding of ISO 13485 and FDA 21 CFR Part 820
• Proven experience writing and executing NCRs, CAPAs, deviation reports, and process validations (IQ/OQ/PQ)
• Proficiency in reading engineering drawings/GD&T and using measurement/inspection tools