Quality Engineer

FOREFRONT MEDICAL INVESTMENT PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

FOREFRONT MEDICAL INVESTMENT PTE. LTD. is seeking a quality assurance professional to support product development, validation and supplier audits in a regulated medical device environment.

You will drive ISO 13485 compliance, lead 8D problem-solving, and coordinate internal and supplier audits while maintaining calibration and 9S programs. Proficiency in English and Chinese is preferred; 2+ years' QA experience required.

Qualifications

• Diploma or bachelor\u2019s degree in quality or engineering.
• Min 2 years in QA for medical devices; plastics injection molding/extrusion preferred.
• Familiar with cGMP, ISO 9001, ISO 13485 and regulatory requirements.
• 8D methodology and 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 development in validation activities, MSA, GR\u0026R, and establishing FMEA, Quality Plan, Inspection criteria, WI, PWI, form.
• Promote quality assurance to ensure conformance with standards and regulations.
• Maintain processes aligned with procedures, work instructions and ISO standards.
• Lead investigations and root-cause analysis for complaints and CAPA.
• Participate in internal audits and continuous improvement projects.
• Coordinate and conduct supplier audits.
• Coordinate with external parties on supplier audits.
• Lead in-house 9S audit program.
• Manage calibration program.
• Perform any duties as assigned.

Skills

Communication skills

Presentation skills

People management

Analytical skills

Education

Diploma or Bachelor\u2019s degree in Quality or Engineering

Tools

Minitab

8D problem solving

Internal Auditor

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