QA Operations Manager

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Date: 14 Sep 2023

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 5807

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.   Ensure Latex, Plastics, Silicone and HME Plants conform to the Quality System Regulation (QSR), MDD or EU MDR, 93/42/ EEC,,ISO 13485:-2016 and other relevant Stds.
2.   Assist Production in quality/regulatory requirements in manufacturing.
3.   Manage routine QA activities in operation areas.
4.   Ensure timely and adequate reporting.
5.   Testing and release of products.
6.   Initiate requests for and follow up on correction actions.
7.   Assist QS Team to conduct internal as well as external audits whenever required.
8.   Raise CAPA whenever required.
9.   Support activities related to product recall or reporting of serious malfunction of products to regulatory bodies.
10.   Manage handling of product non-conformities.
11.   Ensure DHR is reviewed prior to final release and certification.
12.   Manage soak test function
13.   To ensure the implementation and maintenance, within the department, of an effective management for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and other legislative requirements

Education / Experience Requirements

Qualification :
Degree in Science or Manufacturing Management System or related discipline.

Experience :
At least 5 years experience in quality field in medical device industry.
Good knowledge of the Quality System Regulation (QSR) and ISO Quality Management System.

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.