Associate Quality Engineer

Date: Sep 10, 2022

Location: Jaffrey, NH, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6932

 

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

The Associate Quality Engineer shall support the Jaffrey NH facility, Value Stream teams and Quality Assurance department in the development, implementation, and maintenance of the quality system, in order to maintain compliance to FDA 21CFR Part 820, ISO 13485 and Teleflex Global and Local procedures.

This position will also provide quality engineering support to manufacturing, engineering, and customer service with activities associated with manufacturing issues and improvement efforts; new product development; process validations and customer complaints.
 

Principal Responsibilities

The primary responsibilities and duties include:
•    Assist QE and VST in execution of daily Quality Assurance activities associated with a designated manufacturing operation. Assist with quality and productivity improvement efforts when identified.
•    Assist or lead nonconformance (product or process) activities including immediate actions, containment, root cause investigation; corrective action and disposition of nonconforming materials during Material Review Board (MRB) meetings. 
•    Assist or lead a Corrective and Preventive Action (CAPA). This includes leading or supporting a specific CAPA through each phase of process – Root Cause investigation; corrective action planning; corrective action implementation; verification of effectiveness (VOE) planning; VOE completion and CAPA closure. 
•    Support the Customer Complaint process through primary investigation activities; inspection of complaint samples; review of manufacturing and inspection documentation; and development of corrective actions on confirmed complaints. Communicate with customers throughout the complaint process. 
•    Support the Quality System through development and revision of procedures, inspection plans, test methods and work instructions.  Become thoroughly knowledgeable relative to the specifications, standards, and required quality processes in the assigned area. 
•    Participate in Internal process audits and support external customer or Notified Body audits, as needed. Support and participate in Supplier audits as needed.
•    Work closely with manufacturing to support process operations and testing requirements.
•    Work closely with new product development engineers and supports protocol, procedure, and specification development. Implement test methodologies. Assist with completion of process validations. Support or lead test method validations.
•    Develops, maintains and approves Inspection Procedures and Test Methods and provides training as required.
•    Assist QE with handling and resolving supplier quality issues (nonconformances and Supplier Corrective Actions).
•    Perform other QA duties as assigned by QE-VST or Quality Manager.
 

Education / Experience Requirements

•    American Society for Quality (ASQ) Certified Auditor or Certified Quality Engineer 
or
•    5 years of Quality Assurance experience working in medical device manufacturing environment
or
•    Bachelor’s degree in engineering, chemistry, physical science or related field  


Additional experience and proven success in the following area or skill: 
•    CAPA and Nonconformance process
•    Customer Complaint Investigations
•    Validation concepts & techniques (process, equipment, and test methods)
•    Continuous Improvement Process/Project Management
•    Process or internal auditing. 
•    Previous experience in generation and revision of Standard Operating Procedures (SOPs) for various quality and manufacturing-related processes, preferred
 

Specialized Skills / Other Requirements

•    Regulatory, CFR, cGMP, QSR and ISO 13485 knowledge base
• Problem-solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc)
•    Proficient in MS Word, Excel required
•    Competent in PowerPoint.
•    SAP ERP knowledge is highly preferred
•    Excellent oral and written communication skills 
•    Ability to prioritize and work independently with limited supervision
•    Excellent interpersonal skills with a demonstrated ability to work in a team environment.
•    Ability to adapt to shifting priorities 
•    Statistical Techniques and experience with Minitab desired (DOE, SPC, Gage R&R),
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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.