Quality Engineer 2
Date: 12 Feb 2025
Location: Kulim, 02, MY
Company: Teleflex
Expected Travel: None
Requisition ID: 11784
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
Position Summary
Individual contributor assisting the Team Lead (Complaint Investigation Lab) and manufacturing sites with all matters related to complaint sample processing and complaint investigations, performed in the Kulim complaint investigation laboratory.
Principal Responsibilities
• Executes complaint investigations and other laboratory functions performed in the Kulim complaint laboratory to ensure quality and timeliness for Regulatory reporting.
• Executes complaint sample processing to maximize efficiencies and integrity of complaint samples.
• Supports complaint sample through-put and complaint investigation timeliness and documents associated processes.
• Supports the Team Lead in relation to interfacing with a variety of internal and external customers including: Global Operations, Manufacturing, Marketing, Research & Development, and Regulatory.
• Supports during regulatory inspections and/or audits as required.
• Utilize SAP, Agile and other systems as warranted for data input and quality record maintenance.
• Utilize sound technical writing to provide clear and concise written internal reports and support external communications as needed to product quality issues.
• Documents laboratory and complaint investigation processes according to established guidelines.
• Notifies manufacturing site(s) of any potential manufacturing issue as a result of a reported complaint.
• Coordinates investigations requiring more in-depth testing with Research & Development.
• Perform other duties as assigned or necessitated by business conditions or changes.
• Adheres to local site (Kulim) protocols and Standard Operating Procedures (SOP) and global Quality Management System (QMS) requirements.
Education / Experience Requirements
• B.S. Degree or equivalent work experience.
• 2-3 years of (medical device preferred) experience.
• Experience with statistical analysis using Minitab and/or Microsoft excel.
• Quality Assurance (ISO13485, 21CFR820) and Risk Management (ISO 14971) experience desired.
Specialized Skills / Other Requirements
• Excellent use of grammar and writing skills.
• Ability to multi-task.
• Experience utilizing ERP system like SAP
• Experience utilizing complaint management system.
• Displays a positive attitude as a Customer Advocate for Teleflex, Inc.
• Participates in departmental initiatives/objectives outside the scope of daily responsibilities.
• Supports regulatory inspections, ISO audits, or corporate audits.
• Consistently performs at a high level for the department.
Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.
Teleflex is an equal opportunities employer.
At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2025 Teleflex Incorporated. All rights reserved.