Singaporean ONLY Quality Engineer (Diploma/ISO 13485/FDA/CFR Part 820)

CVista HR Consulting Pte Ltd; Singapore; On-site; SGD 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Quality Engineer to maintain and improve quality standards within their organization. This role involves developing inspection and testing methods, supervising inspection teams, and ensuring compliance with regulatory bodies. The ideal candidate will have a strong background in mechanical or electromechanical engineering and relevant experience in a manufacturing environment. This is an excellent opportunity to contribute to workplace safety and health while participating in corporate social responsibility initiatives. Join a forward-thinking company that values quality and innovation.

Qualifications

• 3-5 years of relevant experience in a manufacturing environment.
• Familiar with ISO 13485 and FDA regulations.

Responsibilities

• Maintains quality engineering programs and standards.
• Directs inspection team and ensures product quality.
• Supports Product Engineering with quality-related issues.

Skills

Quality Engineering

Inspection Standards

Testing and Evaluation

Statistical Tools

Geometric Dimension and Tolerance

Education

Diploma/Degree in Mechanical Engineering

Diploma/Degree in Electromechanical Engineering

Diploma/Degree in Electronics Engineering

Diploma/Degree in Manufacturing Process Technology

Tools

Inspection Equipment

Statistical Tools

Job description

Responsibilities:

1. Maintains quality engineering programs, standards and improvements within the organization.
2. Develops and initiates standards and methods for inspection, testing and evaluation based on medical device standards.
3. Devise sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data.
4. Develops and implements methods and procedures for disposition of discrepant materials.
5. Directs inspection team engaged in measuring, inspecting and/or testing products or parts and tabulating data concerning materials, product or process quality and reliability.
6. Executes the inspection/testing of new equipment capability.
7. Supervises inspection team on the inspection plan.
8. Supports Product Engineering and Program Manager with customer interfaces as necessary on quality related issues.
9. Provides liaison to various regulatory bodies.
10. Responsible for authorizing the release of final products to customer.
11. Contributes to the workplace safety and health improvement for the employees, as well as environmental protection, by adhering to the company’s Environmental, Health and Safety policies and procedures, and helping to achieve EHS objectives and targets through participation of EHS programs.
12. Participate and adhere to Corporate Social and Environmental Responsibility (CSER) policy, programs and procedures.

Requirements:

1. Singaporeans ONLY
2. Diploma/Degree in Mechanical Engineering/Electromechanical Engineering/Electronics Engineering/Manufacturing Process Technology or related discipline, preferably with at least 3-5 years’ relevant experience in manufacturing environment.
3. Familiar with ISO 13485 Quality System Requirements/US Food and Drug Administration (FDA)/CFR Part 820 regulations.
4. Familiarity with inspection equipment, statistical tools, Geometric Dimension and Tolerance knowledge will be an advantage.

Qualified or interested candidates, please submit your updated resume in MS format by using the Apply Now Button or email to irene.lee(at)cvistahr.com.

Candidates are also encouraged to contact our office where our approachable Consultants will address any inquiries and advice you with relation to this job advertisement. Our dedicated HR Consultants will get in touch with shortlisted candidates for a confidential discussion.

R23112063 | EA License 16C7883