Sr. Quality Engineer, Design Assurance

Date: 18-Jan-2023

Location: Kulim, 02, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 7603

 

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

•    Report to the Quality Engineering group, work with R&D, RA, Manufacturing and other stakeholders to improve product reliability
•    Responsible for investigating, analysing and correcting problems in quality, production and control at manufacturing location
•    Develop, implement and monitor manufacturing quality assurance and quality system activities
•    Review and approve engineering test protocols or process validation protocols
•    Conduct product validations activities and update Quality Engineering and the Design team 
•    Participate in new product development, testing and qualification of transferring products.
•    Proactively identify and help implement improvement plans for Product and Process Quality and carry out risk assessments. 
•    Initiate and follow-up on non-conformances in partnership with the manufacturing sites and suppliers to ensure effective root cause analysis and corrective action implementation.
•    Responsible for completing Corrective Action and Preventive Action (CAPA) process for the design office.
•    Perform periodic audits of Supplier Quality Systems for the purpose of assuring continued Supplier conformance to the quality system requirements.
•    Execute and track effective Change Controls for design, quality and regulatory process  
•    Participate in compliance activities (eg. QMS audits, Specifications Review, Change Control, MDR workstreams) 
•    Develop positive relationships and effective lines of communication with stakeholders
•    Maintain the professional competence, knowledge, and skill necessary for the satisfactory performance of all assigned responsibilities•    Perform any other relevant and related responsibilities that may be assigned from time to time as required by superior.
 

Education / Experience Requirements

•    Degree in Industrial / Mechanical Engineering or other related field.
•    Knowledge of Lean Manufacturing or Six Sigma will be an added advantage.
•    Certified Internal Auditor of ISO 13485 quality management system.
•    Minimum 7 years’ working experience in a manufacturing environment.
•    Technical knowledge or experience in materials and engineering background. 
•    A solid understanding of the medical device industry
•    Knowledge of the OEM market-place is a plus
•    Experience in Change Management as well as Manufacturing processes  (Lean Manufacturing, NPI, etc.) preferred
•    Experience in geometric measurement systems and mechanical testing
•    Experience in process validations and microbiological laboratory work is a plus 
•    A “hands-on” practical approach to reporting problems and offering solutions.

Specialized Skills / Other Requirements


•    Must be able to communicate fluently (written and verbal) in English, Mandarin and Malay Language.
•    Strong project management and problem solving skills
•    Meticulous at work and result oriented.
•    Able to work independently 
•    Able to travel at short notices
•    An excellent communicator with strong interpersonal skills at all level.

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.

© 2021 Teleflex Incorporated. All rights reserved.