Sr. Compliance Specialist

Date: Oct 11, 2021

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4897

 

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

•    Lead the NCE/CAPA team responsible for executing NCEs and CAPAs at the site.
•    Manage NCE and CAPA quality system metrics to ensure system effectiveness.
•    Provide training and mentorship to NCE/CAPA owners, ensuring robust and compliant documentation.
•    Identify opportunities to continuously improve the NCE/CAPA process.
•    Support multiple functions through maintaining and improving an effective and compliant quality system.

Principal Responsibilities

•    Ensure processes needed for the NCE/CAPA processes are documented and controlled.
•    Maintain effective, efficient, and cohesive NCE/CAPA processes which ensures compliance with internal requirements, as well as external (FDA, ISO, etc.) requirements and expectations.
•    Perform database/system functions to carry out NCE/CAPA processes (e.g. Agile)
•    Partner with NCE and CAPA owners in cross-functional departments to manage NCEs and CAPAs and complete them in a timely manner, including providing support during investigation, determining corrections and/or corrective and preventive actions, identifying implementation strategy, and determining statistical-based verification of effectiveness criteria.
•    Develop, implement, and maintain meaningful NCE/CAPA metrics to measure the quality system performance.
•    Monitor and report on the performance of the NCE/CAPA processes to Site Level and Executive Management.
•    Leads QSRB (Quality Systems Review Board) - driving NCE/CAPA execution, oversight, and escalation.
•    Supports organization and facilitation (front and backroom) of FDA, Notified Body, and Supplier audits and inspections.
•    Support Management Review and Integration activities.
•    Partners with Regulatory and/or departments to execute compliance-related strategies.
•    Partners with technical teams to ensure quality system enables success while maintaining compliance.
•    Initiate, prioritize, and lead optimization opportunities to increase effectivity and efficiency.
•    Implement corporate strategic initiatives and execute at a site level.

Education / Experience Requirements

•    Bachelor’s Degree required
•    Four to six years of relevant experience required

Specialized Skills / Other Requirements

•    Ability to manage and set work direction for a team of QA Specialists.
•    Ability to lead cross-functional teams for project execution.
•    Identify, define, drive, and support strategic initiatives for Quality Assurance.
•    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.

Working Conditions / Physical Demands

•    Environment is mainly office, though manufacturing floor visits may be necessary at times
•    Sit for extended periods of time
•    Able to sit, stand, and walk through facility
•    Occasionally lift up to 20 pounds
•    Manual dexterity for office equipment, including computer, keyboard, and mouse, as well as laboratory equipment such as rulers, calipers, pin gauges, microscopes, etc.
•    Position is required to travel offsite and may require domestic and/or international air travel 

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®, 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.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Minneapolis