Job Information
Teleflex Compliance Engineer, Quality Systems in Mansfield, Massachusetts
Compliance Engineer, Quality Systems
Date: Aug 14, 2024
Location: Mansfield, MA, US
Company: Teleflex
Expected Travel : Up to 25%
Requisition ID :10658
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
Under guidance of the Quality Manager and other Teleflex global resources, this position supports adherence to the applicable regulations and standards. Improves and maintains the quality system in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA) and regulatory requirements applicable to the Quality Management System (QMS). The role will also involve multi-site collaboration with Teleflex Medical offices in addition to other departments.
Principal Responsibilities
• Clear understanding of FDA and rest of world compliance trends and application of regulatory compliance principles in medical devices to assist projects.
• Ability to directly apply skill sets in medical device design, design controls, and process validation.
• Ability to identify appropriate standards and apply knowledge to development and remediation of design history files/technical files.
• Experienced in Software as a Medical Device (SaMD) and software validation.
• Working knowledge of US FDA quality system regulations, ISO 13485:2016, ISO 14971, EU medical device regulations (MDR), in vitro diagnostic regulations (IVDR).
• Ability to support 510(k) and other applications at CDRH/FDA.
• Ability to evaluate validation packages for compliance to applicable regulations and standards.
• Experience developing communications to regulatory bodies, submissions, providing written responses, notifications, and updates, attending agency meetings.
• Experience working with cross functional teams such as R&D, Marketing, Operations, Regulatory Affairs.
• Ability to perform gap analysis on a revised standard and execute deliverables to ensure continuous compliance to applicable current standards and regulations.
• Diverse background in various classes and families of devices, product codes, as well as materials.
• Ability to analyze complex data across sources to identify quality signals.
• Ability to solve complex problems in quality, including management of non-conformances, deviations and CAPA.
• Ability to offer detailed, practical, and compliant solutions to identified quality system and regulatory gaps.
• Ensures the promotion of awareness of applicable regulatory and QMS requirements throughout the organization.
Education / Experience Requirements
• Bachelor of Science degree in related field.
• Minimum of 3+ years’ experience of working in the medical device industry.
• Knowledge of international standards and quality tools.
• Knowledge of MS Office.
• Ability to prioritize and work under set deadlines.
• Highly organized self-starter who is detailed oriented with drive and enthusiasm for quality.
• Must possess excellent communication skills, both verbal & written
• Ability to work in a fast paced, team-oriented work environment.
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Specialized Skills / Other Requirements
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.