Senior Quality Engineer

Date: Jun 1, 2021

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4049

 

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.

 

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

The Senior Quality Engineer’s primary responsibilities are leading, managing and driving improvement in 5 main areas of the Quality Management System, in support of Corporate Quality Objectives:  
o    CAPA & Nonconformance (NC) Processes;
o    Incoming Inspection Improvements;
o    Perpetual Audit readiness;
o    Product Complaints identified as manufacturing-related;
o    Quality Improvement efforts related to Global or Local initiatives, such as Cost Improvement Projects 
Additionally, this position will also support the Operations, Engineering, R&D and Post Market Surveillance team activities to ensure that product quality and services are achieved, maintained, and improved.
 

Principal Responsibilities

1.    Support Nonconformance process including: 
a.    Coach and drive NC investigation, containment and corrections while tracking progress; performing follow-up; and ensuring timely and effective completion;
b.    Facilitate daily Material Review Board meetings when deemed necessary;
c.    Identify & create trend analysis for Nonconformance quality indicators to initiate CAPA and improvement efforts.
d.    Incoming Inspection Improvements.
2.    Lead and manage the CAPA process and system by: 
a.    Lead CAPA related to Quality organization;
b.    Supporting and coaching CAPA leaders through the CAPA process;
c.    Leading monthly CAPA meetings when deemed necessary;
d.    Reviewing and/or participating in root cause analysis, corrective action identification and verification of effectiveness planning. 
3.    Assist with Supplier Quality management process, including supplier evaluations, supplier corrective action requests and evaluation of supplier change notification requests. Conduct supplier audits for Chelmsford site, as necessary.
4.    Lead Perpetual Audit readiness activities and conduct internal or process quality audits as needed (i.e. MDSAP, External Audits, Internal Auditor program).
5.    Support product complaint investigations and participate in post market surveillance activities. 
6.    Lead assigned Quality Improvement project or Quality Objective related initiative. 
7.    Support product and/or process qualification utilizing validation for design and process FMEAs.
a.    Participate in design and phase reviews when deemed necessary;
b.    Incorporate Design of Experiments (DOE) and other statistical tools within the validation process. 
8.    Support risk management policies and procedures.
9.    Interface with various internal and external resources such as Manufacturing Product Development, Marketing, and Regulatory Affairs to assist with Post Market Surveillance, Product Complaint or Regulatory submissions.
10.    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
 

Education / Experience Requirements

Education
•    Bachelor of Science required; Engineering concentration preferred.
•    ASQ Certified Quality Engineer or Certified Quality Auditor preferred. 

Experience
7+ years of Quality and/or related Manufacturing/Engineering experience in a manufacturing site with the following skills:
o    CAPA, Nonconformance and MRB lead or management role;
o    Planning, controlling and assuring product and process quality; 
o    ISO 13485 and MDSAP regulation knowledge and experience;
o    Medical Device Complaint Handling;
o    Quality System management and deployment experience;
o    Risk management;
o    Problem solving and quality improvement, including quantitative methods;
o    Design Controls;
o    Validations (product and process IQ/OQ/PQ);
o    Supplier Quality Engineering (i.e. Supplier Audits, Inspection Techniques).
 

Specialized Skills / Other Requirements

•    MDSAP experience (backroom/frontroom/Subject Matter Expert); Supplier Audits; Internal Audits; Calibration; QA and Incoming Inspection. 
•    Knowledgable of ISO 13485, ISO 14971, and FDA QSR requirements
 

 

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: Boston