Senior Supplier Quality Engineer

Date: Sep 8, 2021

Location: Wallingford, CT, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4417

 

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

Interfacing with Supply Chain, R&D, Design Assurance and Manufacturing Teams, this Wallingford, CT based Senior Supplier Quality Engineer is responsible for Supplier Quality Management for Teleflex’s Z-Medica portfolio of hemostatic medical devices. This position acts as a valuable resource for areas including qualification, issue resolution, change management, and performance monitoring of Suppliers within a highly regulated Medical Device manufacturing environment.

Principal Responsibilities

•    Perform periodic audits of Supplier Quality Systems to assure continued Supplier conformance to the Quality System requirements
•    Initiate and follow-up Supplier Corrective Action Requests (SCARs) in partnership with impacted cross-functional groups to ensure complete and effective root cause analysis and corrective action implementation
•    Prepare and negotiate Quality Agreements with Suppliers
•    Assess potential new Suppliers for technical, quality, and manufacturing capabilities
•    Manage, review, and approve Supplier Change Requests and partner with Sustaining Engineering, Regulatory, and Supply Chain to develop and implement appropriate strategies to support qualification through the change approval process
•    Lead the investigation, resolution, and prevention of Supplier-caused nonconformances
•    Recommend and drive continuous improvements in the Supplier Quality organization to improve the related systems and processes at Teleflex
•    Create and/or maintain Supplier Quality procedures
•    Create and maintain strong relationships and effective lines of communication with Suppliers
•    Develop partnerships across multiple facilities with Supply Chain, R&D, Design Assurance, and Manufacturing groups
•    Collaborate with Suppliers on continuous improvement activities at the Supplier’s site to improve product quality and Supplier performance
•    Assist with the acquisition of new companies and/or the integration of new suppliers into the Quality System
•    Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
•    Support Risk Management effort from Supplier Quality perspective
•    Adhere to and ensure compliance to the Teleflex code of conduct, all company policies, rules, procedures, and housekeeping standards
•    Other responsibilities assigned to support the Quality System as needed
 

Education / Experience Requirements

•    BA/BS in Engineering or physical sciences
•    5-10 years of experience working within an FDA regulated industry, Medical Device preferred.
•    Advanced knowledge of 21 CFR 820, ISO 13485, and relevant regulations (MDD, MDR etc.).
•    Minimum 3 years of auditing experience (3rd party certification preferred).
•    Certification preferred (ASQ CQE and/or CSQP).
 

Specialized Skills / Other Requirements

•    Ability to leverage, influence and/or engage others to accomplish projects
•    Self-starter with the ability to quickly learn about new processes, projects, and requirements
•    Strong verbal and written communication skills, including the ability to write technical reports / presentations and to negotiate Supplier Quality Agreements
•    Solid organizational and follow-up skills, as well as attention to detail
•    Advanced problem-solving skills and root cause analysis experience
•    Critical thinker with analytical problem-solving skills, able to resolve quality-related issues in a timely and effective manner
•    Knowledge of quality-related tools including, but not limited to, SPC, DOE, TMV, and Quality Systems
•    Experience with various process-improvement methodologies, such as Six Sigma and Lean Manufacturing
•    Knowledge of advanced statistics and data analysis
•    Working knowledge of US and international medical device regulations, standards, and guidance documents. Such as:
o    21 CFR 820 US FDA Quality System Regulations
o    ISO 13485:2016 Medical Devices – QMS – Requirements for Regulatory Purpose
o    MDD 93/42/EEC Medical Device Directive (European)
o    Regulation (EU) 2017/745 Medical Device Regulations
•    ISO 13485:2016 Lead Auditor Certified, or similar Lead Auditor certification (ASQ CQA, for example)
•    Experience with applications such as Word, Excel, PowerPoint, SharePoint, Minitab
 

Working Conditions / Physical Demands

•    Ability to sit, stand, walk throughout the day as needed in an office and light manufacturing/assembly environment to perform tasks.
•    Fine and gross motor skills to perform tasks using standard office equipment including frequent keyboarding, computers, peripherals, phones, and other devices as required.
•    Ability to communicate clearly both in writing and using spoken communication, with or without assistance.
•    Ability to read, comprehend and appropriately act upon detailed written information at an advanced level, with or without assistance.
•    Infrequent lifting of up to 20 pounds may be required.
•    Infrequent bending, crouching, twisting, kneeling, pushing, or pulling in and around cleanroom and assembly areas.
 

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

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.


Nearest Major Market: New Haven
Nearest Secondary Market: Hartford