Senior QA Manager (SPP-546)

Date: 15-Feb-2021

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 3379

 

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

Global Operations is a complex and diverse organization within the company which is responsible for product fulfillment to all our customers from end to end.   We pride ourselves on being totally Customer Centric in our unrelenting focus on Quality, Service and Value as perceived by our customers.
We focus on attracting, developing and retaining the best people at all levels of our organization to deliver our commitments to our customers.  
This is a key position in the execution of strategic projects in Global Operations.  There are a number of projects being initiated to drive Teleflex’s profitability and operational excellence into the future.  This role is an integral part of a new team with responsibility for executing these projects in line with our values without compromise on Quality of products or customer’s needs. 
This position requires a Senior QA Leader with the ability to manage a very broad set of activities, as described below:
 

Principal Responsibilities

•    Ensure appropriate quality assurance strategies, including sterilization, for the transfer projects as determined by Global Operations are defined in co-operation with the strategic manufacturing leadership team and implemented.  
•    Stay abreast of quality management system changes, notifying the key stakeholders of changes that may impact the overall project timelines and update plans accordingly.
•    Ensure compliance to Global quality management system requirements, Quality System Regulation (QSR), CMDCAS, ISO 13485:2003, MDD, Malaysia MDR and GDPMD and Other Site Standards.
•    Identify need for new/updated quality policies/processes to facilitate the manufacturing transfers. 
•    Detailed analysis, review and tracking of all aspects of quality assurance and sterility assurance activities and requirements associated with manufacturing transfers.
•    Ensure effective communication and act as liason and partner with quality assurance operations, regulatory(internal and external to Teleflex), quality systems, sterility assurance, product development and sales & marketing personnel to ensure project success.
•    Support due diligence activities in assessment of manufacturing transfer requirements.
•    Proactively manage people and team issues, actively resolves conflicts and build the organizational capabilities to deliver results now and into the future.
•    Demonstrate  initiative and critical thinking to analyze cost issues, develop solutions and lead the team to deliver improving results.
•    Exemplify Teleflex Core Values and ensures a fair, open and productive climate. Serves as a leader to leverage and institutionalize continuous improvement thought processes.  
•    Attract, retain and develop people within the team. 
•    Ensures an ethical and legally compliant atmosphere. 
•    Provide other support requested by management

Education / Experience Requirements

•    Microbiology, Biology, Medical Technology or Other Appropriate 4 Year Degree, MS Degree Preferred
•    8-10 year’s experience Quality Assurance and Sterility assurance. 
•    Extensive knowledge and understanding of US and international medical device regulations, standards and guidance documents.
•    Extensive knowledge and understanding of ISO13485, 21CFR820 quality management system requirements. 
•    Extensive Project Management skills and experience.
•    Lean Six Sigma, CQE, CQA, ASQ certifications preferred
 

Specialized Skills / Other Requirements

•    Excellent verbal and written communication skills;
•    Experience with leading and participating in several projects concurrently.
•    Ability to accurately scope projects and consider the full impact of decisions and actions taken.
•    Effective presenter of issues, facts and ideas to senior members of the organization. 
•    Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts
•    Excellent interpersonal skills and ability to participate with cross functional teams in projects and innovation.
•    cGMP, QSR knowledge and ability to work within/navigate with ease
•    Ability to communicate and to present reports & ideas.
•    Functional Expert in quality with a passion for excellence.
•    A leader, innovative and imaginative with a forward looking approach and commercial outlook.
•    Displays ownership of results and a drive to achieve 
•    Must be fluent in English  (Native or bilingual proficiency) 
•    Complex problem solving skills for developing creative solutions and meeting objectives are required.
•    Manage personnel directly or indirectly to achieve the objectives of the applicable strategic project.
•    Self motiviated to achieve compliant results.
•    Good business acumen.
•    Attention to detail and accuracy – essential.
 

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.