Quality Engineer

Date: 18-Jun-2022

Location: Singapore, 01, SG

Company: Teleflex

Job Purpose

The individual filling this position will have a total experience of four years to six years in quality management systems supporting a manufacturing environment or a strategic business unit.  The position is based in Teleflex Singapore office.  It is responsible for QMS operations and maintenance, product specifications updating and releasing, quality system projects, internal & external audits, new product introduction support and assisting the QMS section lead and the Quality department head in managing the strategic business unit’s QMS functions.

 

 

Key Responsibilities

Key responsibilities will include (but are not limited to) the following:

 

  • Hands-on experience in QMS function with focus in Good Documentation Practices of documentation control with procedures, technical drawings, external standards and technical reports
  • Liaise between head office/ manufacturing sites/ subcontractors/ suppliers/ external auditors / internal customers on quality system matters
  • Trained in ISO 13485 Lead/Internal Auditing.  Has some experience in regulatory bodies’ audits (eg. FDA inspection) 
  • Conduct QMS internal & external audits and support supplier audits when necessary
  • Participate in Quality System Review Board meetings and Technical Review meetings to report quality metrics and quality system compliances and training progress
  • Support Management Reviews and tracking key quality metrics and objectives
  • Updates product artwork files for labeling releases
  • Appointed as Quality System Training Engineer to coordinate and/or conduct internal training on all procedures changes and quality system requirements
  • Participate actively in quality system projects to improve the quality system and efficiency of monitoring and reporting
  • Support Quality Engineering projects such as new product introduction, product quality improvement, Medical Devices Regulations and other regulated standards’ compliances

 

 

Key Relationships / Interfaces

  • Senior Quality Manager
  • QMS Lead
  • QARA group, International
  • QARA group, US
  • External notified bodies and auditors
  • Subcontractors and suppliers


Essential Skills / Experience

  • Professional degree/diploma in Quality/ Engineering/ Science/ Business
  • 4~6 years’ experience in QMS in a medical product manufacturing environment
  • Experience in external bodies (eg. FDA, Regulatory) audits, corporate audits, suppliers audits and internal audits
  • Possess critical thinking skills and a forward-looking approach, receptive to changes and adaptive to different off-site environments
  • Displays ownership of processes and results, a drive to achieve the next level and meeting departmental goals
  • Excellent interpersonal skills and ability to participate with others in projects, keeping quality system in compliance and be creative in solutions
  • Ability to communicate and to present reports & ideas to the department manager and able to go the extra mile to get things done.  A doer and a thinker.
  • Proficient in using Microsoft Office, Auto-CAD or SolidWorks are necessary.

 

Behaviors / Values

For this key position we want a person with good organizational and analytical skills, a team player with hands on experience in quality systems management and who has already worked in an international/ MNC environment.   He or she should be able to resolve problems with inter-department collaboration and not lose sight of quality objectives.  This person should be meticulous, a flair for details, and able to plan ahead of time to fulfill the QMS objectives.   

 

A high level of communicative skills, the ability to persuade and assertion are expected as well as the ability to work under pressure, with limited resources and time.  Quick comprehension, thinking in terms of the big picture and organizational skills are essential as well as the ability to integrate and get along with people of differing backgrounds and agendas.   

 

Must be able to establish positive work credibility in the organization as a person who can align and collaborate with strategic intentions and to show by positive character traits and attitude that others will follow to achieve the necessary outcomes.

 

Note:  As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities will evolve and change over time.

 

Expected Travel: None

Requisition ID: 6387

Teleflex is a global provider of 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, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference.

Position Summary

Principal Responsibilities

Education / Experience Requirements

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.

© 2021 Teleflex Incorporated. All rights reserved.