Manufacturing Quality Analyst

Date: 25-Nov-2021

Location: Kulim, 02, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 4872

 

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

SPC and SAP
•    Involved in SPC program setup, implementation and monitoring of the program. Ensure user expectation are met during the testing process. Support technically to identify and resolve issue. Coordinate and provide training for the team on the SPC
•    Involved in SAP program and involved on the setup, implementation and monitor of the program. Ensure user expectation are met during the testing process. Support technically to identify and resolve issue. Coordinate and provide training for the team on the SPC
•    Motivate and display leadership by displaying Teleflex core value.
•    Provide knowledge transfer, training to the new user 
•    Undertake special project as required and contribute to continuous improvement activities
•    Ensure ongoing compliance with quality and industry regulatory requirement 
•    Develop and maintain QC / QA document related to the project 
•    Perform root cause analysis and analyzed statistical data 
•    Perform any other relevant tasks as and when required by superior
•    Timely Escalation and Reporting
•    Work with the cross functional team to drive Site Objectives

Incoming 
•    Oversee and manage day to day incoming inspection activities and ensure no back-lock item and material released on time.
•    Ensure Incoming QC personnel trained and able to successfully perform tasks in compliance with regulations and internal procedures.
•    Create/revise procedures that govern the Incoming QC activities. 
•    Review and approved incoming inspection record
•    Authorized to provide inspection status based on written acceptance criteria.
•    Responsible to manage and control of Identification Sticker Issuance
•    Suggest improvement and/or develop new QC inspection methods (PMS).
•    Responsible to enforce GMP Practice in incoming areas.
•    Responsible to provide information for Supplier monitoring and MRB Meeting
•    Responsible to control Incoming Inspection area, as well as HOLD Area
•    Maintain all measuring and testing equipment for incoming inspection and environmental monitoring in good condition
•    Collaborate in failure analysis and investigations.
•    Maintain 5S, protection to environment, ensuring safety and healthy at all time.
•    Report incoming material inspection trending and incoming material inspection status & backlog.
•    Lead and develop incoming inspectors.
•    Work with procurement to ensure sufficient material to production.
 

Education / Experience Requirements

•    Diploma holder in Manufacturing, Engineering or Science discipline with minimum 3 years working experience in QA department.
•    Degree holder in Manufacturing, Engineering or Science discipline with minimum 1 year working experience in QA department.
•    Experience in working in Manufacturing and QA environment is compulsory.

Specialized Skills / Other Requirements

•    Must be able to communicate fluently (written and spoken) in English and Bahasa Malaysia
•    Process improvement skill, analyzing information and root cause analysis, statistical analysis. 
•    Attention to details, thoroughness, and good in dealing with Complexity project
•    Knowledge in CGMP, Process validation, Molding, Assembly process, ISO13485 and other medical devices requirement is an added advantage.
•    Proficient in Microsoft word, excel and power point is required. Knowledge in Minitab is and added advantage. 
•    Ability to work in fast pace environment is required.
•    Preferably with knowledge in statistical analysis.
•    Meticulous at work and result oriented.
 

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.