Posted in Other 15 days ago.
Expected Travel: Up to 10%
Requisition ID: 4980
Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
In accordance with quality control and quality assurance principles, and under limited supervision, this Wallingford, CT based Quality Engineer is responsible for Teleflex's Z-Medica portfolio of hemostatic medical devices and provides quality engineering 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 in assigned area and ensures that all necessary systems are in place and effective. Thoroughly understands and applies statistical methods to product and process development efforts. Is accountable for a broad range of technical assignments in assigned quality engineering area under limited supervision. May lead or review the work of quality technicians and have impact on quality status of significant dollars of plant product.
o Identify and Lead continuous improvement projects as agreed with management. Lead personnel 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.
o Become thoroughly knowledgeable relative to the specifications, standards, and required quality systems in assigned area. Write/Revise procedures and specifications as necessary.
o Work on assigned projects under limited supervision. Provide supervisory responsibilities on projects for technicians, inspectors, contract resources, interns, etc. as required or directed by the Quality Manager.
o Knowledgeable in researching, writing and performing Installation Qualification (IQ), Operation Qualification (OQ), and Process Qualification (PQ) validation protocols.
o Knowledgeable in writing and maintaining CAPA's and Non-Conformances. Track internal quality issues and report on corrective action progress, including performing failure investigation and making recommendations for corrective actions.
o Support and evaluate current test and inspection methods to identify areas for improvement, efficiency and cost reductions.
o Partner with affiliated disciplines, (i.e., Regulatory Affairs, Quality Engineering, New Product Development, Operations, Supplier Management) to assure that adequate design controls and/or procedures are complied with and met to facilitate design transfer activities.
o Work closely with new product development engineers and supports protocol, procedure, and specification development. Implement test methodologies.
o Work closely with technology personnel in understanding, developing, and executing statistically designed experiments.
o Work closely with suppliers in process development. Use statistical methods as appropriate.
o Work closely with product development and purchasing to ensure supplier controls are complied with and met per procedures.
o Assists the associate quality engineer in maintaining the metrology system per procedures, schedules required calibrations and works closely with all outside calibration companies.
o Maintain and improve mastery of technical information and knowledge that impacts area of statistical expertise through seminar attendance and/or professional certifications.
Education / Experience Requirements
o BS degree in engineering, life science or related field. MS preferred. MBA a plus.
o Minimum of 2 years related quality experience in a manufacturing environment
o Minimum of 1-year experience in the medical device field
o Broad experience in manufacturing operations, including new product development and implementation, process qualification, cost reduction, and quality engineering
o 6 sigma black belt preferred
Specialized Skills / Other Requirements
o Regulatory, cGMP, QSR, ISO knowledge base
o Proficient with Microsoft Office, including Word, Excel, and Outlook (i.e., data-base development, statistical software and analysis, simulation, word processing for report generation, etc.)
o Strong project management skills
o Strong negotiation and problem solving skills
o Team Development
o Strong attention to detail and deadlines
o Outstanding written and verbal communication skills including the ability to effectively communicate with a broad spectrum of people with varying backgrounds, education and experience
o Strong statistical Skills (e.g., DOE, SPC, Reliability, Gage R&R).
o Professional Certification (e.g., ASQ - CQA, CQE and/or CRE; RAB, internal / external courses, seminars) preferred
o Strong reasoning ability to support and prioritize projects, adapt to shifting priorities, work with minimal supervision and ability to resolve problems / conflicts
o Ability to operate with appreciable latitude for actions or decisions on day-to-day activities. Receives guidance on novel or controversial problems.
Working Conditions / Physical Demands
o Ability to sit, stand, walk throughout the day as needed in an office and light manufacturing/assembly environment to perform tasks
o Fine and gross motor skills to perform tasks using standard office equipment including frequent keyboarding, computers, peripherals, phones, and other devices as required
o Ability to communicate clearly both in writing and using spoken communication, with or without assistance
o Ability to read, comprehend and appropriately act upon detailed written information at an advanced level, with or without assistance
o Infrequent lifting of up to 20 pounds may be required
o Infrequent bending, crouching, twisting, kneeling, pushing, or pulling in and around cleanroom and assembly areas
WAGE RANGE: $85,000 - $95,000 per year based on experience and qualifications
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.
about 17 hours ago
about 17 hours ago
about 22 hours ago