QA Engineer

Role Overview

• Project management and development with process validation experience;
• Quality issue handling;
• Production & Process audit
• Ensure suppliers are clear on all Company and International standards, processes and procedures as they relate to various medical devices.
• Perform in line and finished product verification in accordance with Company and International Standard to ensure acceptable quality.
• Work with other functional team (QA and PM) to determine appropriate testing parameters for the products to ensure limited failures in product.
• Lead the sample evaluation, process validation, and performance testing during the new product development phase. And fulfil the technology transfer to SQE/QC team.
• Perform process audits and identify opportunities for continuous improvement on process control, production control and quality control.
• Be responsible for projects with vendors from a quality perspective, more specifically, on product design change, quality performance improvement, and monitoring quality performance on critical products.
• Work with Suppliers and Company corporate office in US to help resolve various customer complaints. Specifically, help with root cause investigations and analysis. Implement CAPAs based on root cause investigations to reduce complaint numbers. Ensure that solutions to quality issues are properly implemented and upheld.
• Work with suppliers and Company QC team in Asia to reduce product rejections.
• Work with suppliers to identify opportunities for product and process improvements that lead to cost savings.
• Work with supplier to validate and optimize the production parameters and ensure suppliers properly document and verify these parameters once implemented.

Requirements

• B.S. Degree in Mechanical Engineering, or Material, or Industrial engineer or Medical device related engineering field required.
• 3+ years of engineer experience, project management is preferred on process control and quality control is required
• Understanding of quality system requirements (ISO 13485 or ISO 9001)
• Excellent English speaking, reading and writing skills.

Benefits

• health insurance
• life and disability
• 401(k) contributions
• paid time off