Supplier Quality Engineer

ADABA PTE. LTD.; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A leading medical device company in Singapore is looking for a Supplier Quality Engineer to manage supplier quality and performance monitoring. Your role will involve onboarding suppliers, ensuring compliance with standards, and collaborating with internal teams for product quality assurance. Ideal candidates will have a relevant engineering degree and experience in quality assurance. This position offers an opportunity to make a significant impact in the medical device industry.

Qualifications

• 1-2 years of relevant experience in Quality Assurance or Supplier Management preferred.
• Expertise in ISO 13485, Regulation (EU) 2017/745, ISO 9001 preferred.
• Working knowledge of FMEA.

Responsibilities

• Participate in supplier management processes including onboarding, selection and approval.
• Evaluate and monitor supplier performance and business risk related to Quality, Delivery, and Service.
• Communicate and collaborate closely with external suppliers and internal stakeholders on qualification projects.

Skills

Quality Assurance

Supplier Management

Interpersonal skills

Documentation management

Education

Diploma or Bachelor in Bioengineering, Materials, or relevant Engineering

Job description

Overview

Job Title: Supplier Quality Engineer
Location: Singapore
Industry: Medical Devices Technology
Reporting to: Quality, Senior Manager

Join our team and play a vital role in our Supplier Quality Management Program. You will contribute to all aspects of supplier quality, including onboarding, performance monitoring, change management, and corrective actions. Your efforts will ensure that the products our customers receive are of the highest quality. This position requires excellent communication and creative problem-solving skills to collaborate effectively with both internal and external stakeholders.

Responsibilities

• Participate in supplier management processes, including onboarding, selection, and approval. This involves assessing supplier profiles, conducting site visits and audits, reviewing supplier quality agreements, and building strong partnerships.
• Develop and manage the Approved Supplier List (ASL) across entities, ensuring a tailored measurement and monitoring framework for each supplier category.
• Evaluate and monitor supplier performance and business risk related to Quality, Delivery, and Service. Collaborate with suppliers to identify opportunities for enhancements and improvements.
• Participate in supplier-related changes through the Supplier Change Management process, evaluating the impact with internal stakeholders using change notices and FMEA risk management.
• Support new product development launches and new supplier/material qualifications by ensuring complete supplier onboarding documentation and that purchased materials meet required standards.
• Communicate and collaborate closely with external suppliers and internal stakeholders (Supply Chain, Incoming Material Engineering, Manufacturing, R&D, and Regulatory Affairs) on supplier/material qualification projects, as well as material quality issues.
• Address purchased material failures/defects and derive preventive and corrective action plans through the SCAR system.
• Gather information from all parties to support the flow of information and identify/support process enhancements.
• Conduct internal audits of internal quality procedures.

Profile of Ideal Candidate / Qualifications

• Diploma or Bachelor of Engineering or Bachelor of Science in Bioengineering, Materials, or general Engineering relevant to medical fields.
• 1-2 years of relevant experience in Quality Assurance, Supplier Management, or a medical device/manufacturing environment is preferred.
• Expertise in applicable standards (ISO 13485, Regulation (EU) 2017/745, ISO 9001, 21 CFR 210/211/820, etc.) or certification in QMS/Lead/Internal Auditing, preferably in ISO 13485/9001 or equivalent, is preferred.
• Working knowledge of FMEA.
• Highly organised with strong documentation management skills.
• Excellent interpersonal and communication skills to build cross-functional teamwork and support.
• Good capabilities in dealing with suppliers.
• Positive working attitude and comfortable managing administrative processes and ad-hoc assignments.

If you are keen to have a preliminary chat, please send your CV directly to [e-mail]

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Adaba Pte Ltd
EA Licence: 25C2727