Quality Engineer II, Product Quality Assurance

Date: Jul 9, 2024

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel : Up to 10%

Requisition ID :10620

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 .

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.

Position Summary

Supports the Product Quality Assurance team analyzing post-market data and potential product quality issues for commercialized devices. Accountable for a broad range of technical assignments in the Quality Assurance area under general supervision and working with cross-functional investigation teams. Understands the fundamentals of root cause investigation, risk management, and medical device Quality Management Systems per 21 CFR 820, ISO 13485 and 14971.

Principal Responsibilities

• Identify the need for, and act upon, nonconformances and CAPAs identified by cross-functional groups when discussing product quality issues.

• Investigate, compile and report on information necessary for executive management to assess if field actions/corrections and removals associated with Teleflex products is warranted.

• Work closely with Manufacturing sites, R&D, Suppliers, Supplier Quality, Marketing, Design Assurance, and Regulatory to investigate and document quality issues.

• Assist with compilation and analysis of product quality metrics for presentation to Global and business unit leadership.

• Utilize statistical techniques to identify rates, changes in trends or estimated occurrences based on bench and field data.

• Utilize sound technical writing to provide clear and concise written internal reports and support external communications as needed to respond to Product Quality issues

• Assist during regulatory inspections and/or audits and present as required

• Utilize SAP, Agile and other systems as warranted for data input and quality record maintenance.

• Communicate and escalate Quality issues appropriately to QA Manager and address other items as assigned by Manager

• Provide technical leadership to junior staff in quality-related technical assessments, including but not limited to problem solving and statistical analysis.

• Lead team in data collection and analysis for risk assessments, Health Hazard Evaluations arising from post-market trending and design-related nonconformances.

Education / Experience Requirements

• BS Degree Engineering (or related technical field).

• 5+ years of experience in medical device or equivalent highly regulated industry.

• Experience with statistical analysis using Minitab and/or Microsoft Excel.

• Quality Assurance (21CFR820, ISO13485) and Risk Management (ISO 14971) experience required

• Experience with Corrective Action and Nonconformance identification and initiation

• Experience with Manufacturing and Design Control concepts desired

Specialized Skills / Other Requirements

• Quality Assurance (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience required

• Experience with Corrective Action, Manufacturing and Design Control concepts desired

• Computer literate (i.e., statistical software and analysis, excel, word processing for report generation, PowerPoint presentations, etc.)

• Positive attitude and ability to operate and communicate effectively with multiple teams & leadership

• Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve problems / conflicts, and proactively effect change

#LI-NR1

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.

© 2024 Teleflex Incorporated. All rights reserved.