Senior Quality Engineer FGO QMS, Global Capability Centre

Work Flexibility: Hybrid

The Senior Quality Engineer, 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 Senior Quality Engineer QMS will oversee and support 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.
What you will do:

· Supports the Quality Management Systems compliance with the appropriate internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements).

· Contribute in developing optimum future state of QMS for business needs, aligned with Corporate, Divisional & SGS QMS.

· Identifies improvements & inputs into the quality planning process.

· Oversee and execute development and/or modification of Stryker's regional/local Quality Management Systems.

· Co-ordinate Management Review and Quality Planning Review & Forums.

· Assess & Quantify requirements for support of QMS to optimum structure under which the service required will be provided.

· Drive GMP and GDP practices within Quality.

· Identify and implement improvement opportunities to increase the efficiency and effectiveness of the Quality Management Systems.

· Develop & deliver training/compliance for QMS group.

· Contribute to the development, maintenance and improvements of the policies and procedures.

· Implement best in class QS practices and benchmark against industry leads and regulatory requirements.

· Liaise and communicate with notified bodies to manage certification changes.

· Ensure QMS reflects actual activities and business needs, and supports NPD requirements

· Supports the business during audits to discuss system functionality.
 

What you need: 

· Bachelor’s degree in a Science, Engineering or related discipline preferred.

· Minimum of 4 years in Quality/Regulatory Affairs environment with 2 years’ experience in a role exposed to Quality Management Systems.

· Fluency in English essential.

Preferred Qualifications:

· Experience working in a regulated environment required.

· Experience in interacting with regulatory agencies (FDA, MoH, TUV).

· Thorough knowledge and understanding of US and International Medical Device Regulations.

· Strong knowledge of Quality Systems (CAPA, Audits, Management review, Quality Planning).

· Knowledge of U.S. Food and Drug regulations, as well as of European and international regulatory/industry guidelines/standards.

· Strong analytical, problem-solving, and data-driven decision-making skills.

· Excellent planning, organization, and multi-tasking abilities.

· Strong communication skills with the ability to communicate effectively across all levels of the organization.

Travel Percentage: 10%