Senior Manager, Design Assurance

Date: 25-Dec-2021

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 5177

 

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

Provide senior leadership for quality and design assurance activities related to the support of new product development and sustaining engineering up to and including technology transfer and commercialization. Supervise the activities and manage the performance of design assurance and other quality engineering staff. Own and support broader business unit objectives and global strategic initiatives.

Principal Responsibilities

1.    Supervise design assurance and other quality engineering personnel. Provide feedback on employee job performance. Conduct performance reviews and recommend personal and professional growth opportunities.
2.    Recruit, hire, onboard, and ensure the training of department additions to address resource needs.
3.    Oversee design assurance activities involved with new product development and improvement, including product and process design, classification of quality characteristics, design inputs and review, technical drawings and specifications, and design verification and validation.
4.    Lead and/or participate in strategic planning and in the formation of department and business unit policies, procedures, organizational structure, and direction.
5.    Identify, track and respond to metrics relevant to the department's performance.
6.    Interact with senior management and engineering personnel to help establish priorities, allocate personnel, define project objectives and determine target completion dates.
7.    Provide subject matter expertise and technical leadership in best-practice quality, reliability, design control, statistics, and risk management tools and techniques throughout all stages of our products' life cycle.
8.    Lead and/or support the development of risk management documentation such as risk analyses, FMEAs, and post-market surveillance documents. 
9.    Lead aspects of the company's improvement, remediation, and compliance projects including external quality system implementation and maintenance.
10.    Participate in the due diligence process for mergers and acquisitions and facilitate the integration of people and technical best practices.
11.    Determine and review product and process testing methodologies and results to ensure reliability. 
12.    Support the establishment of design limits for new and modified products and the identification of essential design outputs.
13.    Champion continuous improvement of manufacturing processes and equipment through lean manufacturing techniques and statistical analysis such as Gage R&R, process capability studies, DOE, and SPC.
14.    Work with counterparts in other business units to implement technical and managerial best practices.
15.    Own, support, and/or approve CAPAs or CAPA phases, NCs, and other corrective action and improvement efforts as required.
16.    Apply project management skills in cost/schedule/resource planning as appropriate and assist others in doing the same.
17.    Ensure compliance to the quality management system as well as national and international standards and regulations.
18.    Review and, as appropriate, modify quality system records and documents to ensure compliance and effectiveness.
19.    Interface with auditors and defend the compliance of the organization's processes and records during internal and external audits.
 

Education / Experience Requirements

•    Advanced degree such as M.S. or M.B.A preferred.
•    Recommended 10+ years of quality engineering or design assurance experience (preferably in the medical device industry).  
•    Recommended minimum of 5 years of management experience
 

Specialized Skills / Other Requirements

•    ASQ certification preferred (e.g. CQE, CQA, CMDA, CRE, CSSGB/CSSBB). 
•    Big-picture, systems thinking
•    Ability to train, mentor, and coach others.
•    Thorough understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820.
•    Proficient in MS Office, and Minitab or other statistical softwares.
•    Strong organizational and time management skills to meet deadlines while managing multiple projects.
•    Strong analytical and critical thinking skills.
•    Proficient in technical report writing and review.
•    Strong verbal and written communication skills. 
•    Foster a positive culture of growth, collaboration, adaptability to change, and achievement.
 

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.