Job Information
Teleflex Compliance Engineer, Quality Systems in Mansfield, Massachusetts
Compliance Engineer, Quality Systems
Date: Nov 7, 2024
Location: Mansfield, MA, US
Company: Teleflex
Expected Travel : Up to 25%
Requisition ID :11319
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
Compliance Engineer I is an entry-level role focused on supporting the company’s regulatory and quality compliance initiatives. 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
Assist in maintaining compliance with ISO 13485, FDA, and MDR requirements by supporting document control, training, and risk management activities.
Help in implementing and maintaining QMS processes related to medical device compliance, including document control, corrective actions, and recordkeeping.
Assist with the preparation and execution of internal audits to assess compliance with applicable regulations and standards.
Support risk management activities (e.g., FMEA) and ensure that risk documentation aligns with regulatory requirements.
Assist with ensuring accurate, complete, and compliant documentation in alignment with regulatory standards.
Participate in training sessions related to compliance and quality and provide support in educating staff on regulatory requirements.
Assists in identifying appropriate standards for development and remediation of design history files/technical files.
Assists in developing communications to regulatory bodies, submissions, providing written responses, notifications, and updates, attending agency meetings.
Assists in performing gap analysis on a revised standard and execute deliverables to ensure continuous compliance to applicable current standards and regulations.
Assists in solving 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.
• 0-2 years experience of working in the medical device industry.
• 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.
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.
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