Work Flexibility: Hybrid or Onsite

This is a permanent Hybrid role in our Anngrove site with full Stryker benefits.

What you will do:

The Staff Specialist, Quality Management Systems (QMS) will be primarily responsible for the development of the quality management system in accordance with relevant regulatory requirements for medical devices.

The Staff Specialist, QMS will oversee and ensure that an effective and efficient quality management system is built and maintained. Has responsibility to ensure all necessary QS regulations are met in order to receive regulatory clearance/ certification.

• Responsible for QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, EU MDR, and individual country requirements).
• Responsible in developing the optimum state of QMS for current and future business needs, aligned with Corporate, divisional & GQO QMS.
• Control and implementation of the development or modification of Stryker's regional/local quality management system
• Support management and coordination of management reviews and quality planning reviews
• Support in identifying and implementing strategic improvements and participation in the quality planning process
• Serve as a Local Process Owner for local Quality System Processes
• Responsible for the management of internal and external audits, leading preparations and back room
• Liaise with notified bodies to manage certification changes.
• Support the implementation of QMS training
• Initiate and support the development, maintenance, and improvement of policies and procedures.
• Assessment and quantification of the requirements of the QMS so that it offers the optimal structure for the services to be provided
• Implementation of best-in-class QS practices and benchmarking against industry leads and regulatory requirements.
• Ensure overall GMP and GDP compliance within Quality.
• Management and implementation of projects to develop and/or modify Stryker’s regional/local QMS, as well as providing direction for the strategy to the entire project team

What you will need:

• Bachelor’s Degree – Level 8 Science or Engineering
• EQF Level 6 or equivalent – EU
• Minimum 4 years of experience in a Quality/Regulatory Affairs function

#IJ

Travel Percentage: 10%