Quality Engineer

Date: May 6, 2022

Location: Mansfield, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 5624

 

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.

 

OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

In accordance with quality control and quality assurance principles, and under limited supervision, provides quality engineering services to an assigned area of more extensive scope and/or several sub-systems of the overall quality system. Thoroughly understands fundamentals of quality systems, details of specifications, and related quality standards in assigned area and ensures that all necessary systems are in place and effective. Thoroughly understands and applies statistical methods to product and process development efforts. Is accountable for a broad range of technical assignments in assigned quality engineering area under limited supervision. May lead or review the work of quality technicians and have impact on quality status of significant dollars of plant product.

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Principal Responsibilities

•    Identify and Lead continuous improvement projects as agreed with management. Lead personnel as assigned. Report on status and progress as required. May be responsible for supervision and performance of one to several quality subsystems or subgroups as assigned.
•    Become thoroughly knowledgeable relative to the specifications, standards, and required quality systems in assigned area. Write/Revise procedures and specifications as necessary. 
•    Work on assigned projects under limited supervision. Provide supervisory responsibilities on projects for technicians, inspectors, contract resources, interns, etc. as required or directed by the Quality Manager. 
•    Track internal quality issues and report on corrective action progress, including performing failure investigation and making recommendations for corrective actions.
•    Support and evaluate current test and inspection methods to identify areas for improvement, efficiency and cost reductions.
•    Partner with affiliated disciplines, (i.e., Regulatory Affairs, Quality Engineering, New Product Development, Operations, Supplier Management) to assure that adequate design controls and/or procedures are complied with and met.
•    Work closely with new product development engineers and supports protocol,  procedure, and specification development.  Implement test methodologies.
•    Work closely with technology personnel in understanding, developing, and executing statistically designed experiments.
•    Work closely with suppliers in process development. Use statistical methods as appropriate.
•    Work closely with product development and purchasing to ensure supplier controls are complied with and met per procedures.
•    Assists the associate quality engineer in maintaining the metrology system per procedures, schedules required calibrations and works closely with all outside calibration companies.  
•    Maintain and improve mastery of technical information and knowledge that impacts area of statistical expertise through seminar attendance and/or professional certifications.  
 

Education / Experience Requirements

•    BS degree in engineering, life science or related field.  MS preferred. MBA a plus. 
•    Minimum of 2 years related quality experience in a manufacturing environment
•    Minimum of 1-year experience in the medical device field
•    Broad experience in manufacturing operations, including new product development and implementation, process qualification, cost reduction, and quality engineering
•    6 Sigma Green Belt preferred, Black Belt a plus
 

Specialized Skills / Other Requirements

•    Knowledgeable in writing and maintaining CAPA’s and Non-Conformances. 
•    Knowledgeable in researching, writing and performing Installation Qualification (IQ), Operation Qualification (OQ), and Process Qualification (PQ) validation protocols.
•    Regulatory, cGMP, QSR, ISO knowledge base
•    Proficient with Microsoft Office, including Word, Excel, and Outlook (i.e., data-base development, statistical software and analysis, simulation, word processing for report generation, etc.)
•    Strong project management skills
•    Strong negotiation and problem solving skills
•    Team Development
•    Strong attention to detail and deadlines
•    Outstanding written and verbal communication skills including the ability to effectively communicate with a broad spectrum of people with varying backgrounds, education and experience
•    Strong statistical Skills (e.g., DOE, SPC, Reliability, Gage R&R).
•    Professional Certification (e.g., ASQ - CQA, CQE and/or CRE; RAB, internal / external courses, seminars) preferred
•    Strong reasoning ability to support and prioritize projects, adapt to shifting priorities, work with minimal supervision and ability to resolve problems / conflicts
•    Ability to operate with appreciable latitude for actions or decisions on day-to-day activities. Receives guidance on novel or controversial problems.
 

 

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 Bedford