Senior Quality Engineer

Date: Jan 19, 2021

Location: Mansfield, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 2723

 

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 assurance 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 and ensures that all necessary systems, details of specifications, and related quality standards are in place and effective. Thoroughly understands and applies statistical methods to product and processes through the Product Design and Development process. Ensures supplier controls are implemented per the required procedures. Is accountable for a broad range of technical assignments under limited supervision. May supervise or review the work of quality engineers, technicians and have impact on quality status of significant dollars of plant product. 

Principal Responsibilities

•    Identify and lead continuous improvement projects as agreed with management. Lead and/or supervise pesonnel 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.
•    Provides support for product/process specifications, standards, and required quality systems in assigned area. Writes/revises procedures and specifications as necessary.
•    Works on assigned projects under limited supervision. Provide supervisory responsibilities on projects for technicians as required or directed by the Quality Manager.
•    Authors protocols or, provides support in performing Installation Qualification (IQ), Operation Qualification (OQ), and Process Qualification (PQ) validation protocols.  Provides statistacally valid sampling plans when required.
•    Supports the quality enginer with maintaining and timely closure of both the CAPA and Non-Conformance quality systems. Track internal quality issues and report on corrective action progress, including performaing 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.
•    Partners with affiliated disciplines, (ie Regulatory Affairs, Quality Engineering, New Product Development, Operations, Supplier Management) through the Product Design and Development Process to assure that adequate design controls and/or procedures are complied with and met.
•    Works closely with new product development engineers and support protocol, procedure, and specification development. Implements test methodologies.
•    Works closely with technology personnel in understanding, developing and executing statistically designed experiments.
•    Works closely with purchasing and product development with onboarding and maintaining supplier files during the development process as well as routine maintenance of all supplier files. 
•    Implements yearly objectives that support overall strategic plan.
•    Ensure full compliance with quality and regulatory requirements.
 

Education / Experience Requirements

•    Bachelors Degree required. Prefer focus in engineering, life science or related discipline. 
•    5 years minimum related quality experience in a manufacturing environment. Experience in the medical device industry preferred. Experience in the Design and Development process preferred.
•    Broad experience in manufacturing operations, including new product development and implementation, process qualification, cost reduction and quality engineering.
•    Prefessional Certification, ie 6 Sigma black belt, ASQ – CQA, CQE and/or CRE; RAB preferred. 
•    Strong regulatory, cGMP, QSR, ISO knowledge base.
 

Specialized Skills / Other Requirements

•    Proficient with Microsoft Office, including Word, Excel, Powerpoint and Outlook (ie database development, statistical software and analysis, simulation, word processing for report generation, etc)
•    Excellent negotiation, problem solving and project management skills
•    Strong attention to detail and ability to meet 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.
•    Ability to use and apply statistical skills, such as DOE, SPC, Reliability, Gage R&R.
•    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 situations.
•    Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
•    Ability to work in a fluid, demanding environment
•    Ability to travel domestically.
 

 

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: New Bedford