Sr. Quality Systems Engineer

Teleflex Maple Grove , MN 55369

Posted 3 months ago

Date: Jan 5, 2020

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 1732

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.

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner and Turnpike Catheters, AC3 Optimus Intra-Aortic Balloon Pump and OnControl Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. 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 senior engineer position supports the complaint handling and post market quality assurance functions through data analyses coupled with proactive escalation of important findings. The position will be responsible for defining a complaint trending program compliant with EU MDR requirements, applying statistical methods, and providing visibility to actionable information to multiple stakeholder departments within the organization.

Principal Responsibilities

  • Evaluate complaint and post market surveillance data on an iterative basis to identify significant trends or signals.

  • Lead activities to escalate or further investigate unfavorable trends in data through appropriate quality system functions.

  • Partner with R&D, Sustaining, Design Assurance, Clinical and other stakeholder functions to draw conclusions from post market data and determine action plans.

  • Communicate results of trend analyses across various levels on a recurring basis to management and product teams.

  • Lead development of regulatory trend reporting content and support ongoing program compliance.

  • Query and prepare data from various internal and external sources in support of regulatory compliance and risk reduction efforts.

  • Participate in regulatory body audits as a subject matter expert on complaint trend analysis and reporting.

  • Support development of responses to regulator inquiries pertaining to post market data.

  • Perform database/system functions to coordinate monitoring programs and produce accurate reports.

  • Identify opportunities and take initiative to improve effectiveness and efficiency of quality system processes.

  • May support non-conforming event process, CAPA investigations related to product complaints, and review of records and processes for relevant data.

  • May individually contribute to project teams for Quality Assurance department projects.

Education / Experience Requirements

  • BA/BS in Engineering, physical sciences, or related field
  • 4-6 years relevant experience in the medical device industry

Specialized Skills / Other Requirements

  • Significant prior experience in a medical device engineering function or Quality Assurance

  • Experience applying statistical methods to interpret data is desired

  • Functional understanding of product risk management processes and outputs is desired (e.g. experience with Hazard Analysis or FMEAs)

  • Experience supporting content development for CAPA, Non-Conformance, or Health Risk Assessment

  • Demonstrate ownership of workload and deliverables

  • Provide direction to cross-functional team members

  • Effective at verbal and written communication at different levels within the organization

  • Proficient in technical writing and interpretation of clinical and technical data

  • Strong interpersonal skills, with demonstrated ability to work effectively within a team and as an individual contributor

  • Foster a positive culture of growth, collaboration, and achievement across the organization

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, Rsch, UroLift and Weck trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, 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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Sr. Quality Systems Engineer

Teleflex