Job Information
Teleflex Quality Engineer II in Jaffrey, New Hampshire
Quality Engineer II
Date: Jun 24, 2024
Location: Jaffrey, NH, US
Company: Teleflex
Expected Travel : Up to 10%
Requisition ID :10560
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. 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
This position provides Quality Engineering leadership to Paste extrusion manufacturing as the lead Quality member on the Value Stream team. The primary purposes and objectives include:
• Nonconformance and CAPA coordination and processing;
• Customer complaint investigations;
• Process & product validations;
• Customer Notification of Change evaluations;
• Internal & external auditing responsibilities and support;
• Quality improvement projects; and
• Maintain compliance with Teleflex Global & local Procedures and Policies
Principal Responsibilities
• Nonconformance (NC) and CAPA processing – lead quality activities with respect to Value Stream Material Review Board coordination; inspection methods, NC containment/correction/closure and CAPAs; and drive improvement through analysis of trend data.
• Customer Complaint Investigations – Primary investigator and facilitator for Value Stream complaint investigation, confirmation and corrective actions. Act as primary customer contact on complaint communications. Drive improvement based on trends.
• Process Validations – guide and review protocol development, validation implementation and report review an acceptance;
• Quality & Cost Improvement Projects – lead and participate on key short term projects on product or process improvements;
• Production & Process Controls – review, change and approve Manufacturing Procedures; Test Method validations; Quality Inspection Plans and Process run sheets
• Auditing – routinely perform internal and process related audits. Participate in vendor audits if necessary. Support the Back Room during FDA and Notified Body audits.
• Documentation Control – perform Customer Product Specification reviews. Initiate Engineering Change Notices and review/approve as needed.
• Training – Perform QA training certifications on new Production operators.
• Support Engineering with New Product Development with quality planning, risk evaluation and validation.
• Perform any additional QA tasks, as assigned by QA Manager or Plant Manager
Education / Experience Requirements
• Bachelor degree is preferred or the equivalent ASQ Certified Quality Engineer certification.
• 5+ years of Quality Assurance experience required.
• Experience in a manufacturing environment, with preference in a regulated or medical industry.
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.
Specialized Skills / Other Requirements
• Knowledge of QSR, CFR, cGMP, and ISO regulations (required)
• Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required.
• Experience with Minitab and SAP ERP is desired.
• Statistical Techniques desired (DOE, SPC, Gage R&R).
• Problem solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc)
• Good listening, verbal and written communication skills
• Excellent interpersonal skills with a demonstrated ability to work in a team environment.
• Ability to prioritize and adapt to shifting priorities is desired
• Ability to work independently with limited supervision
• ASQ Certified Quality Auditor highly desired
• Design Control and Risk Management experience desired
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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: 877-880-8588 or Talent@Teleflex.com.
Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, 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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