Senior Quality System Engineer
Date: 13 Apr 2024
Location: Kamunting, 08, MY
Company: Teleflex
Expected Travel: None
Requisition ID: 8902
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
1. Leads Complaints management which includes entire operations of complaints, related indicator ownership and SAP Complaints ownership.
2. Improve on Complaints Management operation to enhance complaint operation and ensuring full compliance to standards and regulations.
3. Liaison with process manufacturing for complaint investigations, reporting and corrective actions.
4. Leads /support issue resolution with manufacturing and customer for complaints and related issues.
5. Owns review, approval and closure of complaints per timelines.
6. Owns timely respond to customer complaint queries and adverse event reporting.
7. Support the initiation and closure of HHE and EIF for site with Quality Systems Manager.
8. Preparation of quarterly, monthly and weekly reports for complaint for various updates of site, regional and global level. Review of all complaint data to ascertain quality of analysis.
9. Undertake effective OSH measures to ensure compliance within the workplace with the Occupational Safety and Health Act 1994 and other legislative requirements.
Education / Experience Requirements
Qualification :
Degree in Science or Engineering related field or Equivalent
Experience :
Experience and knowledge Quality system requirements.
Good understanding in EN ISO13485, FDA QSR and MDD or EU MDR
Computer skills in Microsoft Office – at least at basic level for Word, Excel and Power Point
Good spoken and written English
Able to work independently with minimum supervision
Specialized Skills / Other Requirements
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.