Quality Engineer
Date: 5 Dec 2023
Location: Kamunting, 08, MY
Company: Teleflex
Expected Travel: None
Requisition ID: 9237
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. Implement QA activities as per established procedures and maintain compliance in the designated manufacturing areas and warehouses.
2. Supervise QA activity in designated manufacturing area and warehouse.
3. To ensure online activities are carried out as per procedure/specifications.
4. To ensure products are released on timely basis meeting customer and regulatory requirements
5. Preparation and publication of Quality analytical reports on timely basis
6. Organize Quality meetings on regular basis with relevant departments
7. Raise process non-conformance report or CAPA wherever required.
8. Support manufacturing in CAPA investigation and customer complaints whenever necessary
9. Verify corrective actions for CAPA and follow up on effectiveness of corrective actions
10. Train Senior Final Audit Supervisor (if applicable)/QA Auditors.
11. To highlight to QA Manager on unusual trends or defects.
12. To ensure the relevant procedures are reviewed and revised to current Quality System requirements.
13. To conduct internal audits /spot checks in production areas when required.
14. Ensure DHR is reviewed prior to final release and certification.
15. To ensure the implementation and maintenance within the workplace of an effective management for occupational safety and health consistent with the requirements of Occupational Safety and Health Act 1994 and other legislative requirement in the workplace.
16. Coordinate Quality Improvement Project
17. Coordinate Ship Hold for the finished goods when required.
18. Review and verify shipment list and certificates.
19. Coordinate and monitor archiving DHR activity.
20. Control and release of product at Final Audit and Final Pack.
21. Work in hand with warehouse team in ensuring safe and good quality finished goods is distributed to customers.
22. Manage, coordinate and monitor soak test activity.
Education / Experience Requirements
Qualification :
Degree in Science (Material, Polymers, Biology, Health Sciences or Chemistry or Quality Management System)
Experience :
Minimum 5 years’ working experience in a manufacturing environment.
Training in Lean Six Sigma or Six Sigma black belt and problem solving tools is an added advantage
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.