Quality System Specialist III
Date: Apr 11, 2024
Location: Maple Grove, MN, US
Company: Teleflex
Expected Travel: Up to 10%
Requisition ID: 10185
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.
Position Summary
The Quality System Specialist III supports multiple functions through maintaining and improving an effective and compliant quality system.
Principal Responsibilities
• Manage assigned portions of the quality system to ensure overall system effectiveness.
• Lead QSRB meetings and prepare presentation slides for discussion.
• Responsible for quarterly Management Review activities and documentation.
• Provide training and mentorship to NCE and CAPA owners.
• Identify opportunities to continuously improve the quality system processes.
• Responsible for identifying, implementing, and reporting metrics to site leadership.
• Ensure processes needed for the NCE system are documented and controlled.
• Maintain effective, efficient, and cohesive quality system processes which ensure compliance with internal requirements, as well as external (FDA, ISO, etc.) requirements and expectations.
• Develop, implement, and maintain meaningful NCE/CAPA metrics to measure the quality system performance.
• Supports organization and facilitation (front and back room) of FDA, Notified Body, and Supplier audits and inspections.
• Ability to lead or support internal audits
• Responsible for site External Standards process.
• Partners with Regulatory and/or departments to execute compliance-related strategies.
• Partners with technical teams to ensure quality system enables success while maintaining compliance.
• Implement corporate strategic initiatives and execute at a site level.
• Assist with global projects to merge into one Quality System.
Education / Experience Requirements
• Bachelor’s Degree required.
• 3 to 6 years of relevant experience required.
Specialized Skills / Other Requirements
• Ability to lead cross-functional teams for project execution.
• Effective verbal and written communication.
• Proficient in technical / systems writing and review.
• Possess interpersonal skills to work in a team and as an individual contributor.
• Ability to collaborate with personnel at all levels both within and outside the company.
• Structured and methodical problem-solving approach.
• Understanding of medical device industry quality system design and management.
• Experience with FDA Quality Systems Regulations, ISO 13485, Quality Certificates, GMP, MDSAP, and EU MDR.
• Ability to foster a positive culture of growth, collaboration, and achievement across the organization.
• Lead or support Quality Systems projects to support compliance to standards.
#LI-EB1
Working Conditions / Physical Demands
TRAVEL REQUIRED: Up to 5 %
WORKING ENVIRONMENT:
☒ Office/Professional ☒ Plant/Manufacturing ☐ Remote/Field ☐ Laboratory
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 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.