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Associate Quality Engineer

Teleflex

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Mansfield, MA
LOCATION

Job Description

As posted by the hiring company

Job Overview:

Expected Travel: Up to 10%

Requisition ID: 6115

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 facility and departments in the development, implementation and maintenance of the quality system. This includes supporting both the quality and manufacturing departments with regards to the applicable QSRs and ISO standards.

Principal Responsibilities

• Under guidance of the Quality Manager, author/participate in equipment/process validation IQs, OQs & PQs for adherence to QSR’s and ISO standards. Provides statistically valid sampling plans when required.
• Coordinate with purchasing and suppliers and identify areas for quality improvements.
• Becomes thoroughly knowledgeable relative to the specifications, standards, and required quality systems in assigned area. Writes/Revises procedures and specifications as necessary.
• Supports the quality engineer & quality manager with maintaining and timely closure of the CAPA quality systems. Track internal quality issues and report on corrective action progress, including performing failure investigations and making recommendations for corrective actions.
• Assist with coordination of Non-Conforming Product program including review root cause analysis, corrective action and disposition of nonconforming materials
• 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.
• Work closely with technical personnel in understanding, developing, and executing statistically designed experiments.
• Under guidance of the Quality Manager, support the development of Risk analysis including process FMEA’s.
• Participate in design review for the purpose of gauging needs and meeting inspection criteria.
• Support the quality technicians with the testing of product when needed and author quality inspection procedure creations or changes when required.

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 the medical device manufacturing environment (a combination of education and experience will be considered)
• Experience in the generation and revision of Standard Operating Procedures (SOPs) for various quality and manufacturing-related processes, preferred

Specialized Skills / Other Requirements

• GMP, QSR, ISO knowledge base required.
• Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint. Ability in data-base development, statistical software and analysis, simulation, word processing for report generation, etc.
• Strong negotiation and problem-solving skills
• Excellent listening, verbal and written communication skills
• Statistical skills preferred (e.g., DOE, SPC, Gage R&R).
• Excellent decision making, time management and reasoning ability
• Excellent interpersonal skills with a demonstrated ability to work in a team
• Ability to multi-task, prioritize, and adapt to shifting priorities
• Ability to work with minimal supervision

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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.