Quality System Manager

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Date: 02-Mar-2023

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 7634

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 compliance to Quality System Regulation (QSR), MDSAP, ISO 13485: 2016, MDD or EU MDR, Malaysia MDR and GDPMD. and Other Site Standards.
2.   Management and Supervision of the above-mentioned direct reports.
3.   Management of Complaint Handling System, CAPA System and Internal Audit System.
4.   Management of Document Control System.
5.   Responsibility for Quality Management Review at Site, Regional and Global Level (as required).
6.   Alignment of Corporate and Site Quality System Procedures.
7.   Support and Site Representative of Quality System Global Harmonization Projects (as required).
8.   Where appropriate, provide relevant Quality support in achieving Site Operational, Finance and Continuous Improvement Goals.
9.   Reporting of relevant Quality Metrics to Senior Management.
10.   Appointed designee for facility quality management representative.
11.   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.
12.   Responsible for calibration of monitoring and measuring equipment on site.

Education / Experience Requirements

Qualification : Degree in Engineering, Science or related discipline.

Experience : Minimum 5 years experience in Quality Management Systems (ideally within the Medical Device Industry)

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.