Associate Quality Engineer

Date: Jun 25, 2022

Location: Plymouth, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6444

 

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 Plymouth MN 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 will begin in a support role to the QE-Value stream team, as appropriate skills and experiences are attained.
•    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 with nonconformance (product or process) process including immediate actions, containment, root cause investigation; corrective action, and disposition of nonconforming materials during Material Review Board (MRB) meetings. 
•    Assist with Corrective and Preventive Action (CAPA) program. This includes leading or supporting a CAPA through each phase of the 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. 
•    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 or 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

•    Bachelor’s degree in engineering, chemistry, physical science, or related field is preferred, or 3+ years of Quality Assurance experience working in medical device manufacturing environment.
•    Previous experience in generation and revision of Standard Operating Procedures (SOPs) for various quality and manufacturing-related processes, preferred. 
 

Specialized Skills / Other Requirements

•    Knowledge of QSR, ISO, or CFR standards and regulations. (Preferred)
•    Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required.  Experience with Minitab and SAP ERP is desired. 
•    Problem-solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc)
•    Excellent listening, verbal, and written communication skills.
•    Previous experience with NC and CAPAs is required.  Experience with customer complaint investigations is desired. 
•    Excellent decision-making, time management, and reasoning ability.
•    Excellent interpersonal skills with a demonstrated ability to work in a team.
•    Ability to prioritize and adapt to shifting priorities is desired.
•    Ability to work with minimal supervision.  
•    Statistical skills desired (e.g., DOE, SPC, Gage R&R).

 

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.

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