Quality Engineer

Forefront Medical Investment Pte Ltd; Singapore; On-site; SGD 45,000 - 70,000; Full time

Job summary

Forefront Medical Investment Pte Ltd in Singapore is seeking a Quality Assurance professional to support medical device manufacturing. You will drive compliance, audit readiness, and continuous improvement across processes, CAPA, NCR, and supplier audits.

The role requires a Diploma or degree in quality or engineering, at least two years in QA, familiarity with cGMP, ISO 13485, 9001, and strong analytical, communication and bilingual English/Chinese skills.

Qualifications

• Diploma or bachelor's degree in quality or engineering.
• Min 2 years experience in Quality Assurance role of Medical Device manufacturing, preferably in plastic injection molding and extrusion.
• Familiar with cGMP, ISO 9001 and ISO 13485 and regulatory requirements; Internal Auditor certification preferred.
• 8D methodology and strong problem-solving skills.
• Good communication and presentation skills.
• People management abilities.
• Good analytical skills and familiarity with Minitab.
• Proficient in English and Chinese; good eyesight.

Responsibilities

• Support new project/product development in validation activities, MSA, GR&R and establishing FMEA, Quality Plan, Inspection criteria, WI, PWI, form.
• Promote and coordinate quality assurance efforts to ensure products conform to quality standards and meet regulatory requirements.
• Maintain and ensure processes are aligned with procedures/work instructions and ISO standards.
• Lead investigations, root cause analysis, resolution and closure of complaints, NCRs and CAPAs.
• Participate in Internal audits and Continuous Improvement Projects.
• Coordinate and conduct supplier audits.
• Coordinate with external party and conduct supplier audits.
• Lead in-house 9S audit program
• Manage calibration program
• Perform any duties as assigned from time to time.

Skills

Quality Assurance

8D Methodology

Problem Solving

Communication

Presentation

People Management

Analytical Skills

Minitab

Education

Diploma or Bachelor's degree in quality or engineering

Tools

Minitab

Job description

Job Description:

1. Support new project/product development in validation activities, MSA, GR&R and establishing FMEA, Quality Plan, Inspection criteria, WI, PWI, form.

2. Promote and coordinate quality assurance efforts to ensure products conform to quality standards and meet relevant regulatory requirements.

3. Maintain and ensure processes are aligned with procedures/ work instuctions and ISO standard.

4. Lead investigation, root cause analysis, resolution and closure of complaint, NCR and CAPA.

5. Participate in Internal audit and Continuous Improvement Project.

6. Responsible for coordinating and conducting supplier audits.

7. Coordinate with external party and conducting supplier audits.

8. Lead in-house 9S audit program

9. Manage calibration program

10. Perform any duties as assigned from time to time.

Job Requirement:

• Diploma or bachelor's degree in quality or engineering

• Min 2 years experience in Quality Assurance role of Medical Device manufacturing, preferrably in plastic injection molding and extrusion.

• Familiar with cGMP, ISO 9001 and ISO 13485 and regulatory requirement, Internal Auditor certified preferred.

• 8D metholody and problem solving skill

• Good communication and presentation skill

• People management

• Good analytical skill and familiar with mini-tab

• Proficient in English and Chinese. Good eyesight