Validation Documentation Engineer
Date: 9 Apr 2024
Location: Kamunting, 08, MY
Company: Teleflex
Expected Travel: None
Requisition ID: 9937
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. Prepare and execute all documentations as per QMS & Change Management process such as CRF, PVP, IQ-OQ-PQ protocols, recording test results, write validation reports, submit for approvals, etc.
2. Work with SQ, RA, QA and relevant global teams to gather information and approvals for projects.
3. Arrange and conduct trainings after completion of projects as per Training requirements.
4. Prepare and Maintain site master validation plan.
5. Review validation are conducted as per protocols.
6. Support Materials Initiatives Validation Team when when needed on other matters related to project planning, execution and closure.
7. Scope – Covers all Procurement related projects for APAC sites
Education / Experience Requirements
Qualification :
Degree in Engineering, Science or Math,
Experience
: Experience in ISO13485, FDA Audit, Process Validations, Change Management.
: 3-5 years experience in validation activities
: Experience in IQ,OQ and PQ testing requirements
: Some knowledge about Regulatory Authority requirements
: Knowledge on MDD and MDR
: Has worked on Master Validation Plan
: Has experience in conducting training on validation and quality related matters
: COF & CRF issuance
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.