About Teleflex Incorporated Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people\xe2\x80\x99s lives. We apply purpose driven innovation \xe2\x80\x93 a relentless pursuit of identifying unmet clinical needs \xe2\x80\x93 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\xe2\x80\x99 lives.

Position Summary

Principal Responsibilities

• Responsible for the issuance and retrieval of all controlled documents generated by the facility and distributed to the company from external source as per requirements defined in the company procedure.
• Responsible for evidence and control of change requests, associated reporting and its archiving
• Motivate and Display leadership by displaying Teleflex core value
• Effectively communicate changes / distribution of controlled documents to recipients and maintain all masters and distributed documents in a state of control.
• Maintain systematic filing system for all controlled documents and correspondences under the responsibility of the QMS Engineer.
• Control, maintain and disposal of obsolete documents and records as per defined in the company procedure.
• Assist on audit preparation and execution, 1st, 2nd and 3rd party.
• Participate in procedure/ work instruction writing, implementation and improvement.
• Compile data and prepare reports for management reviews and meeting.
• Assist QMS Engineer in Regulatory Affairs related matters.
• Responsible for external archive control
• Support the coordination for Change Control Board
• Assign item master numbering and maintain record
• Assist in any job assigned by direct superior
• Timely Escalation and Reporting
• Work with the cross functional team to drive Site Objectives

Education / Experience Requirements

• Diploma holder in science discipline (preferably) or minimum 2 years working experience in QA department
• Experience in Medical Devices Regulatory Affairs will be an advantage.
• Experience in conducting QMS audit will be an advantage.

Specialized Skills / Other Requirements

• Proficient in using Microsoft office.
• Must be able to communicate fluently in written and oral English and Bahasa Malaysia.

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