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Vice President QA/RA in Kloten, Switzerland at Nobel Biocare

Date Posted: 3/11/2019

Job Snapshot

Job Description

Job ID: NOB002926

About Us

Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.


Description

The Vice President of QA/RA will direct activities of the Quality Assurance and Regulatory Affairs organization to include systems, policies and procedures required to ensure that all products fulfill all legal requirements and conform to the established standards of quality and uniformity across the company’s manufacturing sites. The products are predominantly Class IIB devices but the increased importance of digitization and integrated software workflows will need to be dealt with.
Org Structure: there are currently 3 direct reports: Head of RA, Head of QA and Head of Compliance. Total team covers 217 employees.


Change management is a key part of the role, especially initially as the new incumbent will continue to chart the course to achieve strategic priorities of Nobel Biocare Systems.


ACCOUNTABILITIES:
  • Development and implementation of a strong and effective RA/QA strategy for Nobel Biocare Systems globally
  • Optimization of both areas of responsibilities regarding the fulfillment of regulatory requirements as well as the requirements as a result of the business strategy
  • Ensure global planning and implementation of the quality and regulatory strategy and standards for all processes and products which are sold by Nobel Biocare Systems
  • Manage how to deal with digital workflow from the regulatory point of view
  • Develop and implement the Quality Vision and related strategies and policies required by the quality organization to support these
  • Optimization and alignment of various RA/QA systems where necessary
  • Ensuring appropriate approvals of for Nobel Biocare Systems products worldwide
  • Ensuring global compliance of all processes and products, related to legal and regulatory requirements together with an understanding of the business approach
  • Manage communication and negotiations with Competent Authorities or Notified Bodies
  • Lead RA / QA team globally
  • Identify training needs and deliver the respective trainings as needed
  • Liase and collaborate with teams in other dental companies

Job Requirements



Qualifications

Qualifications: 
  • MS or PhD in a natural science discipline and/or in mechanical engineering.
  • Knowledge of the applicable regulation such as ISO 13485, 21 CFR820, JPAL. Knowledge of production processes preferably in the production of implants and prosthetic components of various materials, CAD/CAM related processes and Software Development.
  • Critical Skills/technical know-how: (what the role holder must be able to do)
  • Proven management leadership skills and ability to build global structures. Proven ability in working in complex, cross-functional and multi-cultural structures.
  • Strong people management skills. Must be accessible and integrative with strong communication capabilities.
  • Hands-on approach, solution-oriented combined with a strategic mindset and driving results. Project Management and team building capability
  • Fluent written and spoken English


Experience:
  • Vast experience in a leadership position in Quality Management and Regulatory Affairs in the medical device industry.
  • FDA experience is a must


Success Factors:
  • Strategic orientation and global alignment of the Quality Management and global regulatory strategy.
  • Achieving and maintaining a compliant state of the Quality Management system.
  • Making pragmatic decisions in accordance with the regulations.
  • Define understandable key metrics to show the status of the Quality Management System.
  • Initiate and drive quality improvements throughout the organization.
  • Identify relevant Quality training needs and deliver the respective trainings. 
  • Keep a high awareness for Quality within the company.

#LI-RN1


Danaher Corporation Overview

Danaher's Dental Platform is a $3B global business focused on all aspects of dental care.  With the intention to spin-off the Dental Platform to become its own public company in the second half of 2019, “Dental Co” will become one of the largest and most innovative dental companies in the world.  We are changing the face of dentistry with our differentiated portfolio of products designed to serve every dental professional’s need. It is our mission to make our dentist's work simpler and better connected so more patients are cared for in a shorter time. Our dental brands include traditional consumables and equipment (KaVo Kerr) and specialty products (Ormco and Nobel Biocare).