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Assistant Manager, L&d QA

4 weeks ago

Klang, Malaysia Teleflex Full time

**Date**:12 Mar 2024

**Location**: Port Klang, 10, MY

**Company**:Teleflex

**Expected Travel**: Up to 10%

**Requisition ID**: 10028

**About Teleflex Incorporated**

**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**
- Drive ProActive Quality improvements and Projects in partnership with related business functions.
- Responsible for the establishment, execution, maintenance and Global Harmonization of the quality management system (QMS), in compliance with ISO13485, GDPMDS
- QMS management and support of the QMS activities including internal, supplier and external audits.
- Perform regular internal audits and trainings to ensure compliance to Teleflex Quality standards and drive pro-active quality improvements in partnership with all related functions.
- Support the commercial Business Units in relation to the complaints and Field Corrective Action (FCA) processes and work with the global organization and local teams to manage, monitor and handle the customer complaints, product holds, recall, rework, etc
- Support the management of quality related hold products in DCs (e.g. Quality Hold, Expired product) ensure processes are compliant to Global requirements with appropriate segregation and identification.
- Perform inspection and test activities associated with the acceptance and finished devices governed by Standard Operating Procedures and/or Drawings.
- Responsible for the implementation and verification of CAPA and NCs.
- Lead/support any required internal review meetings.
- Support the implementation of local labelling (Value Added Service-VAS) and Rework control systems to adhere to regulations/Teleflex internal procedures.
- Any other activities as assigned by the QA Manager SEA+.

**Education / Experience Requirements**
- Bachelor’s Degree /diploma in Quality/ Engineering/ Science
- Minimum 5 years’ experience in QA in a manufacturing or distribution environment, preferably related to Medical Devices or Pharmaceutical
- Experience in subcontractors/ suppliers management and communication
- Experience in warehousing quality control, manufacturing processes
- Ability to use Quality Tools such as benchmarking, gap analysis, pareto analysis, fish
- bone diagrams, and process mapping for fact base decisions making.
- Good understanding of ISO13485:2016 and experience in quality system auditing.
- Strong project management and troubleshooting skills, desired.
- Ability to prioritize, adapt, take initiative and uphold integrity
- Possess leadership qualities, 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
- Change management.
- Excellent interpersonal skills and ability to participate with others in projects and innovation
- 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 Word, Excel, Power Point, Visio, SAP etc.

**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._

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