Date: Jun 10, 2019
Location: Coventry, CT, US
Expected Travel: Up to 10%
Requisition ID: 1091
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.
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.
- Under guidance of the Site QE Supervisor, direct equipment/process validation IQs, OQs & PQs for adherence to QSR’s and ISO standards.
- Support the definition of site KPIs (Key Performance Indicators) and develop and implement visual tracking chart methods
- Conduct statistical analysis on KPIs and product performance data to monitor trends and identify improvement opportunities
- Coordinate with suppliers and identifies 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.
- Assist with coordination of Corrective and Preventive Action (CAPA) program for customer, internal, and vendor related needs.
- 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 technology personnel in understanding, developing, and executing statistically designed experiments.
- Under guidance of the Site QE Supervisor, lead in development of control plans.
- Assist with Risk Analysis including Process FMEA’s as applicable.
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 in a medical device environment, preferred
Specialized Skills / Other Requirements
- cGMP, QSR, ISO 13485 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.
- ASQ Certification (CQA, CQIA, CQE, Green Belt) preferred
- 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
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.
© 2018 Teleflex Incorporated. All rights reserved.