Quality Assurance Specialist

6 days ago

Singapore beBeeQuality Full time

Job Title: Quality Assurance Specialist

About This Role

We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team. As a key member of our organization, you will be responsible for ensuring that all products meet the highest quality standards.

Key Responsibilities:

  • Participate in supplier quality management programs, including Approved Supplier List (ASL) management, supplier on-boarding process, supplier change management, supplier quality agreement review, supplier corrective action system, and supplier performance and audit evaluation.

  • Achieve high-quality products by communicating and effecting creative solutions with internal and external stakeholders.

  • Develop and manage the ASL across entities, ensuring proper measurement and monitoring frameworks tailored for each supplier category.

  • Evaluate and monitor supplier performance and business risk evaluation on the Quality, Delivery, and Service aspects, collaborating with suppliers to identify opportunities for enhancements and improvements.

  • Support new product development launches and/or new supplier/material qualification, ensuring all supplier on-boarding related documentations and actions are complete, and the quality of purchased material meets required standards and expectations.

Requirements

  • Bachelor's degree in Engineering or Bioengineering, Materials Science, or a related field relevant to medical fields.

  • 1-2 years of experience in Quality Assurance, Supplier Management, or a medical device/manufacturing environment.

  • Expertise in applicable standards, such as ISO 13485, Regulation (EU) 2017/745, ISO 9001, 21 CFR 210/211/820, etc.

  • Working knowledge of FMEA.

  • Excellent interpersonal and communication skills to build cross-functional teamwork and support.

  • Possess positive working attributes and comfortable managing admin processes and ad-hoc assignments.

Preferred Qualifications

  • Experience with QMS/Lead/Internal Auditor certification in ISO 13485/9001 or equivalent.

Skills

  • Strong analytical and problem-solving skills.

  • Excellent communication and interpersonal skills.

  • Ability to work in a fast-paced environment and prioritize tasks effectively.

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