Staff Specialist, Quality Management Systems

Job Summary

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

Work Flexibility

Hybrid - You can expect to regularly work in both an alternate workplace and a Stryker facility. The expectation to be onsite is defined and agreed upon by the manager.

Remote - The role allows you to work the majority to 100% of time from an alternate workplace. Any travel expectations remain within the country of the job location.

Field Based - You can expect to regularly work a majority to 100% of time at customer facilities and have a set territory or travel within a set boundary.

Onsite - The role is 100% located at a Stryker facility.

Responsibilities

• Develop the quality management system in accordance with relevant regulatory requirements for medical devices.
• Oversee and ensure that an effective and efficient quality management system is built and maintained.
• Ensure all necessary quality system regulations are met to receive regulatory clearance or certification.
• Maintain QMS compliance with internal and external regulatory requirements (Site, Division, Corporate, FDA, ISO, EU MDR, and individual country requirements).
• Develop an optimum state of QMS for current and future business needs aligned with Corporate, Division & GQO QMS.
• Control and implement development or modification of Stryker's regional/local quality management system.
• Support management and coordination of management reviews and quality planning reviews.
• Identify and implement strategic improvements and participate in the quality planning process.
• Serve as a Local Process Owner for local Quality System Processes.
• Manage internal and external audits, lead preparations and back room activities.
• 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.
• Assess and quantify QMS requirements to offer the optimal structure for services.
• Implement best in class QS practices and benchmark against industry and regulatory requirements.
• Ensure overall GMP and GDP compliance within quality.
• Manage and implement projects to develop and/or modify Stryker's regional/local QMS and provide strategy direction to the entire project team.

Qualifications

• 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.
• Proficiency in QMS development and regulatory compliance across multiple regions.
• Strong communication and project management skills.
• Ability to travel up to 10% of the time.