Senior Quality Engineer

Date: Jan 23, 2023

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 7617

 

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

The Sr. Quality Engineer will be responsible for cross-functional quality assurance, quality management/compliance, quality control, and activities associated with all Teleflex products and processes with a focus on manufacturing activities.  In support of Corporate Quality Objectives, the incumbent will lead, manage, and drive improvement in 5 main areas of the Quality Management System including CAPA & Nonconformance (NC) Processes; Incoming Inspection Improvements; Perpetual Audit readiness; Product Complaints identified as manufacturing related; and Quality Improvement efforts related to Global or Local initiatives, such as Cost Improvement Projects.  Additionally, the Sr. Quality Engineer will support the Operations, Engineering, R&D, and Post Market Surveillance team activities to ensure that product quality and services are achieved and maintained.

Principal Responsibilities

•    Nonconformance (NC) and CAPA processing – lead quality activities such as inspection methods, NC containment, correction, closure and CAPAs; and drive improvement through analysis of trend data. 
•    Support Incoming & In-Process Inspection teams.
•    Prepare QSRB and QMR slides as needed.
•    Support the Value stream with investigations required for field corrective actions including risk evaluation.
•    Perform internal audits and support supplier corrective actions as needed.
•    Quality & Cost Improvement Projects – lead and participate in key short-term projects on product or process improvements;
•    Production & Process Controls – review, change and approve manufacturing procedures; test method validations; Quality Inspection plans and Process run sheets. 
•    Auditing – routinely perform internal and process-related audits. Participate in vendor audits if necessary. Support the Back Room during regulatory and notified body audits. 
•    Documentation Control – perform change controls (ADC/ECOs) as needed. 
•    Training – Perform QA training certifications on new production operators as needed.
•    Support Engineering with new product development with quality planning, risk evaluation, and validation. 
•    Perform any additional QA tasks, as assigned by QA Manager or Plant Manager. 
•    Maintain compliance with Teleflex Global & local procedures and policies.
•    This position requires direct contact with an implantable device.      ☐ Yes     ☒ No 
 

Education / Experience Requirements

•    Minimum 4-year degree in an Engineering discipline – Mechanical, Biomedical, Plastics, Industrial, etc. 
•    ASQ Certified Quality Engineer or Certified Quality Auditor preferred. 
•    Minimum 5 years experience of Quality and/or related Manufacturing/Engineering experience in a manufacturing site with the following skills:
•    CAPA, Nonconformance and MRB lead or management role.
•    Planning, controlling and assuring product and process quality .
•    ISO 13485 regulation knowledge and experience with MDSAP.
•    Medical Device Complaint Handling.
•    Quality System management and deployment experience.
•    Risk management
•    Problem-solving and quality improvement, including quantitative methods.
•    Design Controls
•    Validations (product and process IQ/OQ/PQ).
•    Supplier Quality Engineering (i.e. Supplier Audits, Inspection Techniques).
 

Specialized Skills / Other Requirements

•    MDSAP experience (backroom/front room/Subject Matter Expert); Supplier Audits; Internal Audits; Calibration; QA and Incoming Inspection. 
•    Knowledgeable of ISO 13485, ISO 14971, and FDA QSR requirements.
•    Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required. 
•    Working knowledge and/or experience with SAP and AGILE is strongly preferred.
•    Good listening, verbal, and written communication skills 
•    Excellent interpersonal skills with a demonstrated ability to work in a team environment.
•    Ability to prioritize and adapt to shifting priorities.
•    Ability to work independently with limited supervision.

TRAVEL REQUIRED: 0-10 %
 

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