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Date: 15 Nov 2024
Location: Kulim, 02, MY
Company: Teleflex
Expected Travel: Up to 10%
Requisition ID: 10335
About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. 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
Principal Responsibilities
Individual supports the Product Quality Assurance Team(s) and manufacturing sites with all matters related to complaint sample processing and complaint investigations; Leads team activities and personnel related to complaint sample processing and complaint investigations performed in the Kulim complaint investigation laboratory.
- Oversees complaint investigations and other laboratory functions performed in the Kulim complaint laboratory to ensure quality and timeliness for Regulatory reporting.
- Oversees complaint sample processing and associated personnel to maximize efficiencies and integrity of complaint samples.
- Maximizes complaint sample through-put and complaint investigation timeliness and documents associated processes.
- Interfaces with a variety of internal and external customers including: Global Operations, Manufacturing, Marketing, Research & Development, and Regulatory.
- Documents laboratory and complaint investigation processes according to established guidelines.
- Uses Teleflex ERP system to perform complaint trend analysis, and to update complaint investigation(s).
- 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.
- Reviews and updates departmental procedures and work instructions.
- Supervises laboratory Quality Engineering personnel performing complaint investigations.
- Perform other duties as assigned or necessitated by business conditions or changes.
Education / Experience Requirements
- B.S. Degree or equivalent work experience.
- 3-5 years of experience performing root cause analysis of technical discrepancies, abnormalities, and product non-conformances.
- 3-5 years of experience preparing laboratory documentation (laboratory procedures, analysis spreadsheets, reference documents, and others).
- 3-5 years of experience working in a regulated environment
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.
- Successfully managed integration of new product introduction or newly acquired products as lead investigator.
- Considerable and invaluable product knowledge gained through training and experience.
- Often noted by customers and sales staff as providing superior service.
- Often seeks additional work outside the scope of daily responsibilities.
- Participates in or leads departmental initiatives/objectives outside the scope of daily responsibilities.
- Participates in 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
Teleflex is the home of Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, 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.
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