全职 Quality Systems Engineer (QMS) 工作, 薪水, Teleflex Perak 公司招聘中 - Ricebowl

Expected Travel: None

Requisition ID: 13803

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit *************

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

• Take part actively in coordinating internal audit and external audit.
• Establish and control the internal audit plans and internal audit schedules as per internal requirements.
• Maintain the audit files according to the procedure.
• Ensures the integrity of the company's Quality Management System in compliance to ISO 13485, MDSAP, MDD or EU MDR and other Regulatory requirements.
• Participate as a lead/ internal auditor during internal audit.
• Act as NC initiator for all internal NC issued on internal audit findings.
• Monitor nonconformance which initiated from internal and external audit and ensure timely reporting and closure.
• Coordinate in external quality system audits to ensure the fulfilment of the requirements of ISO 13485, MDSAP, MDD or EU MDR, and GDPMD, and other relevant regulatory requirements and international standards.
• Maintain the records of the competency of internal auditors.
• Ensure latest global procedure is effectively implemented on site.
• Undertake effective OSH measures to ensure compliance within the workplace with the Occupational Safety and Health Act 1994 and other legislative requirements.
• Data Integrity Oversight:
• Monitor systems, processes, and documentation to ensure data integrity compliance.
• Coordinate/ conduct training and awareness initiatives for staff to ensure understanding and compliance with quality standards and data integrity practices.
• Standard and Regulatory Monitoring:
• Stay current with applicable regulations/guidelines regarding quality audits and data integrity.
• Maintaining standard and regulation watchlist. Meeting cadence for Technical Review Board (TRB) Meeting for Standard & regulation monitoring.
• Monitoring the overall remediation activity of the watchlist for standards in all product families. Provide support in retaining the latest standard updates impacting Kamunting site and ensure gap assessment is in place for all standard revisions.
• And any other assignment/ task deemed fit.
  
  
  

Qualification

Education / Experience Requirements

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.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

2026 Teleflex Incorporated. All rights reserved.