Regional Supplier Quality Manager, North America & EMEA

Date: Dec 31, 2021

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 5053

 

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.

 

US COVID-19 Vaccination Requirements

Teleflex is focused on the health and safety of our employees, their families, and our customers. Teleflex will comply with US government regulations regarding COVID-19 vaccination requirements for US workers. To ensure we are prepared for all applicable vaccination requirements, Teleflex is currently collecting vaccination status and accommodation requests from our US based employees.

Employees and new hires in sales or field-based roles that require vendor credentials to access medical facilities as an essential function of the job, may be required to obtain the COVID-19 vaccination based on customers/site requirement. This requirement is independent of Teleflex policy or any applicable US governmental regulations.

 

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

Position is directly accountable for managing Supplier Quality engineering functions across multiple sites in Notrh America & EMEA. The role will include staffing, developing, and managing a Supplier Quality Engineering team to effectively support and execute supplier qualifications, supplier maintenance, quality agreements, supplier auditing, SCARs, and supplier-driven changes. Additionally, this role will drive initiatives for optimization of Quality System deliverables and processes, and foster a positive culture of growth, collaboration, and achievement across the organization.

This position can be located in Maple Grove, MN or Chelmsford, MA

Principal Responsibilities

•    Manage, mentor, and develop Supplier Quality Engineering teams at each of the facilities but also as in a Regional context.
•    Manage teams in support of development and production, including the selection, qualification, and maintenance of suppliers.
•    Demonstrate expertise and drive compliance with company policies/procedures, ISO 9001, ISO 13485, FDA QSRs, EU MDR, and other applicable standards.
•    Establish strategic direction for the Regional Supplier Quality group, aligned with Global Supplier Quality strategies and including objective and goal setting.
•    Assess Supplier Quality Engineering metric performance, and report to leadership teams.
•    Identify, define, drive, and support strategic initiatives for Supplier Quality Engineering.
•    Drive continuous improvement in Supplier Quality Engineering systems with a focus on best-in-class processes and procedures that enhance compliance and produce business efficiencies.
•    Develop and maintain strong relationships and effective lines of communication with internal and external customers, as well as suppliers. 
•    Support internal, external, and customer inspections and Quality System audits, including preparation and direct interaction with auditors.
•    Partner with New Product Development, Operations, Supply Chain, Microbiology, and Quality Assurance on organizational, procedural, and strategic initiatives and implementation.
•    Provide guidance to teams through technical, system, and execution challenges.
•    Partner cross-functionally to scope, staff, support, and prioritize improvement projects.
•    Engage with Quality Assurance to execute and manage supplier-related non-conforming events.
 

Education / Experience Requirements

•    BA/BS in Engineering or physical sciences required, master’s degree preferred.
•    Minimum Five years of related experience required.
•    Three years of experience managing/supervising a team.
 

Specialized Skills / Other Requirements

•    Ability to coach, direct and develop a high performing team of engineers and technicians.
•    Ability to structure and direct teams in alignment with cross functional teams.
•    Establish work direction and supervision of Supplier Quality Engineering staff across all relevant sites.
•    Experience with quality-related tools including, but not limited to, SPC, DOE, and TMV; experience with various process-improvement methodologies, such as Six Sigma and Lean Manufacturing.
•    Communicate team and project status to senior management.
•    Ability to define, organize, and manage individual and team tasks with appropriate prioritization.
•    Effective verbal and written communication. 
•    Proficient in reviewing, assessing, and advising on technical topics.
•    Interpersonal skills; working cross-functionally, in a team, and as an individual contributor.
•    Thorough understanding of design/process/supplier controls, risk management, statistics, and production.
•    Minimum 3 years’ experience with US and international medical device regulations, standards and guidance documents. Including:
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
o    ISO/IEC 17025:2017 – General Requirements for the Competence of Testing and Calibration Laboratories
•    Project Management skills and experience.
 

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: Minneapolis