Expected Travel: Up to 10%
Requisition ID: 7090
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.
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.
• The Sr. Quality Engineer is responsible for cross-functional quality assurance, quality management/compliance, quality control, and activities associated with all Teleflex products and processes with a focus on manufacturing activities.
• The Sr. Quality Engineer is responsible for leading, managing, and driving improvement in 5 main areas of the Quality Management System, in support of Corporate Quality Objectives:
o CAPA & Nonconformance (NC) Processes
o Incoming Inspection Improvements
o Perpetual Audit readiness
o Product Complaints identified as manufacturing related
o Quality Improvement efforts related to Global or Local initiatives, such as Cost Improvement Projects
• Additionally, this position will also support the Operations, Engineering, R&D, and Post Market Surveillance team activities to ensure that product quality and services are achieved, maintained
• Provide quality engineering support in the development and manufacturing of new and existing disposable medical devices.
• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations.
• Work with manufacturing engineering to validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Interface with various internal and external resources such as Manufacturing Product Development, Marketing, and Regulatory Affairs to assist with Post Market Surveillance, Product Complaints, or Regulatory submissions.
• Work with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP).
• Support Nonconformance process including:
• Coach and drive NC investigation, containment, and corrections while tracking progress; performing follow-up; and ensuring timely and effective completion
• Facilitate daily Material Review Board meetings when deemed necessary
• Identify & create trend analysis for Nonconformance quality indicators to initiate CAPA and improvement efforts.
• Incoming Inspection Improvements.
• Lead and manage the CAPA process and system by:
• Lead CAPA related to the Quality organization
• Supporting and coaching CAPA leaders through the CAPA process
• Leading monthly CAPA meetings when deemed necessary
• Reviewing and/or participating in root cause analysis, corrective action identification, and verification of effectiveness planning.
• Assist with Supplier Quality management process, including supplier evaluations, supplier corrective action requests, and evaluation of supplier change notification requests. Conduct supplier audits for the Chelmsford site, as necessary.
• Lead Perpetual Audit readiness activities and conduct internal or process quality audits as needed (i.e. MDSAP, External Audits, Internal Auditor program).
• Support product complaint investigations and participate in post-market surveillance activities.
• Lead assigned Quality Improvement project or Quality Objective related initiative.
• Support product and/or process qualification utilizing validation for design and process FMEAs.
• Participate in design and phase reviews when deemed necessary
• Incorporate Design of Experiments (DOE) and other statistical tools within the validation process.
• Support risk management policies and procedures.
• Adhere to and ensure compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures, and housekeeping standards.
• Support Quality Management System (process development, creating and editing new and existing SOPs).
• Lead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs)
• Resolve incoming inspection yield issues by driving tighter vendor process capabilities and ensuring appropriate internal drawing tolerances
Education / Experience Requirements
• Minimum 4-year degree in an Engineering discipline - Mechanical, Biomedical, Plastics, Industrial, etc.
• ASQ Certified Quality Engineer or Certified Quality Auditor preferred.
• 4-6 years of Quality and/or related Manufacturing/Engineering experience in a manufacturing site with the following skills:
• CAPA, Nonconformance, and MRB lead or management role
• Planning, controlling, and assuring product and process quality
• ISO 13485 and MDSAP regulation knowledge and experience
• Medical Device Complaint Handling
• Quality System management and deployment experience
• Risk management
• Problem-solving and quality improvement, including quantitative methods
• Design Controls
• Validations (product and process IQ/OQ/PQ)
• Supplier Quality Engineering (i.e. Supplier Audits, Inspection Techniques)
Specialized Skills / Other Requirements
• MDSAP experience (backroom/front room/Subject Matter Expert); Supplier Audits; Internal Audits; Calibration; QA and Incoming Inspection.
• Knowledgeable of ISO 13485, ISO 14971, and FDA QSR requirements
TRAVEL REQUIRED: As needed < 10%
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.
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