Expected Travel: Up to 10%
Requisition ID: 11000
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 SummaryThis position provides quality assurance and engineering leadership for process development and manufacturing.
The primary purposes and objectives include:
• Nonconformance/CAPA coordination and processing
• Customer complaint investigations
• Process & product validations
• Customer notification of change evaluations
• Internal & external auditing responsibilities and support
• Supplier quality issues and change support
• Lead Quality improvement projects
• Maintain compliance with Teleflex Global & local Procedures and Policies
Coaching, mentoring and supervision of other quality personnel may be assigned and required.
• Nonconformance (NC) and CAPA ownership and participation
• Customer Complaint ownership and participation; Act as primary customer contact on complaint communications.
• Process Validations – guide and review protocol development, validation implementation and report review an acceptance.
• Quality & Cost Improvement Projects – lead and participate in product and/or process improvement projects.
• Production & Process Controls – review, change and approve Manufacturing Procedures; Test Method validations; equipment qualifications, Quality Inspections and more to ensure product confirms to specifications.
• Auditing – routinely perform internal and process related audits. Participate in supplier and customer audits as necessary. Support the Back Room during FDA and Notified Body audits.
• Documentation Control – perform document reviews and updates, including ownership of Engineering Change Notices as needed.
• Supplier Quality – provide support on incoming material quality, on NCs and Supplier Corrective Actions (SCARs). Also participate in evaluation of any supplier or supplier material changes (SCNs).
• Training – Perform QA training certifications on new Production operators.
• Support Engineering with New Product Development with planning, risk evaluation, controls, validation and more to help with successful product transfer into manufacturing.
• Perform any additional QA tasks, as assigned by QA Manager or Plant Manager.
• Other duties as assigned.
• Minimum of Bachelor degree required. Degree in a related field or technical focus, preferred.
• Minimum of 5 years of QA or engineering experience, required.
• Experience in a manufacturing environment, regulated or medical industry preferred.
Additional experience and proven success in the following area or skill is preferred:
• CAPA and Nonconformance process
• Customer Complaint Investigations
• Validation concepts & techniques (process, equipment, and test methods)
• Continuous Improvement Process/Project Management
• Process or internal auditing.
• Regulatory, CFR, cGMP, QSR and ISO 13485 knowledge base
• Problem solving skills and experience with Root Cause Analysis tools
• Statistical Techniques and experience with Minitab desired
• Competent in MS Word, Excel, & PowerPoint. SAP ERP knowledge is a plus.
• Good oral and written communication skills
• Ability to prioritize and work independently with limited supervision
• Ability to adapt to shifting priorities
• Excellent interpersonal skills with a demonstrated ability to work in a team environment.
• ASQ Certified Quality Auditor highly desired
• Design Control and Risk Management experience desired.
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At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
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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