Sr Manager, Corporate QMS Audits

Date: Feb 14, 2024

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 9470 

 

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 Functions The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. 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 position reports to the Sr Director, Quality Systems. This role is required to assess and provide a clear global vision of Corporate Quality Management System (QMS) Audits across the Teleflex organization through driving strategy, direction, management, and oversight of the global Corporate QMS Audit Program including its role in potential mergers and acquisitions.

Improve and maintain the Corporate Audit program 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

  • Provide strategic oversight to the Corporate QMS Audit program through creation of an improvement roadmap and detailed plan including communication
  • Develop and maintain the Corporate QMS procedures and work instructions to maintain compliance to applicable regulations, standards, and business requirements that will evaluate the health and effectiveness of internal processes and procedures
  • Develop and lead a training and qualification program for Corporate and internal site QMS auditors
  • Maintain records of auditor qualifications, certifications and training
  • Develop, maintain and adhere to global Corporate QMS Audit schedule
  • Review and approve Corporate QMS Audit plans and reports
  • Provide supervision and training as required for direct reports to perform Corporate QMS audits. Support direct reports in gaining knowledge of all applicable standards, regulations, procedures and work instructions per individual development plans
  • Responsible for collection, production, and publication of compliance data and metrics related to Corporate QMS audits for Quality Data reviews including Management review and analyze data and metrics to provide Teleflex leaders with a health assessment of the Global QMS.
  • Interface with all sites and site stakeholders for assistance in areas of auditing
  • Develop general audit training content and train necessary personnel.
  • Identify and implement Audit Key Performance Indicators to reflect effectiveness, speed and efficiency.
  • Support QMS due diligence activities with respect to potential mergers and acquisitions including completion of due diligence reports on health of QMS
  • Support and lead additional activities as assigned by Sr. Director, Quality Systems or Executive Leadership

Education / Experience Requirements

  • Bachelor of Science in Engineering or other technical degree.
  • Experience with Quality Management Systems and medical device regulations
  • Experience with regulatory inspections/audits
  • Experience and knowledge of risk management and CAPA systems

Specialized Skills / Other Requirements

  • Excellent organizational skills
  • Excellent written and verbal communication skills

#LI-AD1

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.