Quality Manager

Date: Oct 28, 2020

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3000

 

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

•    Leader for the Quality Assurance team in Chelmsford MA site.
•    Management Representative responsibilities for the Chelmsford MA site; organize and lead external audits.
•    Drives execution on quality deliverables – monitors and reports on site quality metrics and addresses issues.
•    Oversight for the site-specific Quality System aligned under global policies.
•    Partners cross functionally including:  Post Market, Design Assurance, Doc Control, Training, and Operations.  
 

Principal Responsibilities

•    Leader for the Quality Assurance team in Chelmsford MA site, which includes:  Quality Engineering, Quality Systems, QC, and Calibration.  
•    Proactively manages performance and team dynamics to ensure that a fair, professional and high-performance environment, aligned with company values is maintained. Develops individual and organizational capabilities to build bench strength while delivering results.
•    Establish, implement, and maintain an effective, efficient, and cohesive site-specific quality system that ensures compliance with FDA and ISO expectations and aligns with overarching global policies. 
•    Responsibility to serve as Management Representative.
•    Organize, lead, and facilitate FDA and Notified Body audits, inspections, and correspondences.
•    Create internal audit schedule and ensure timely execution.
•    Drive pragmatic, responsive, and timely execution on Non-Conformances and CAPAs.
•    Manage and report on site quality metrics – monitoring, planning, and executing to improve performance.
•    Identify and respond to trends and quickly address underperforming metrics.
•    Partner with Design teams to ensure the successful transfer of new designs from development to production.
•    Partner with Operations to maintain supply continuity, execute validations and drive continuous improvement.
•    Support Supplier Quality in the execution of supplier audits, additions, changes, and requests.
•    Support Post Market in complaint investigations, risk assessments, and field actions.
•    Identify, execute, and collaborate cross functionally on manufacturing scrap and cost reduction projects.
•    Identify, drive, and support optimization and harmonization opportunities to increase effectivity and efficiency.
•    Provide input into regional and corporate strategic initiatives and execute at a site level.
•    Execute and make decisions with limited supervision; quickly and clearly escalate issues as appropriate.
 

Education / Experience Requirements

•    B.S. Degree in Engineering or Physical Sciences required. Master’s Degree or MBA preferred.
•    Minimum of 5 years related quality experience in a manufacturing environment.
•    Minimum of 2 years’ experience supervisory or management experience.
•    ASQ CQA or CQE certification preferred
 

Specialized Skills / Other Requirements

•    Can establish work direction and manage a team of engineers and technicians.
•    Capable of defining, organizing, managing, and executing individual and team tasks.
•    Ability to collaborate with various levels within and outside the company, as well as across functions.
•    Effective verbal and written communication – to team, peers, and management. 
•    Statistical and engineering knowledge (DOE, SPC, sampling, validation, tolerance analysis)
•    Pragmatic and methodical root cause analysis and problem-solving approach.
•    Strong understanding of medical device industry regulations and quality system design/management. 
•    Experience with FDA Quality Systems Regulations, ISO 13485, Quality Certificates, GMP, and MDSAP.
•    Knowledge of controlled environment monitoring and controls.
•    Ability to foster a positive culture of growth, collaboration, and achievement across the organization.

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.

© 2020 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Boston