Senior QMS Specialist
The Senior 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 Senior Specialist 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.
- 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 & GQO QMS.
- actively engage in set up and local maintenance of strategic quality tools in the site, just as Corrective & preventive action system, training systems and document control
- 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.
Qualifications
- Quality/Regulatory Affairs environment experience in a role exposed to Quality Management Systems.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
- Thorough knowledge and understanding of US and International Medical Device Regulations.
- Strong knowledge of Quality Systems (e.g. CAPA, Audits, Management review, Quality Planning).
- Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
- Strong written and oral communication and negotiations skills.
- Strong in critical thinking and "outside the box" thinking.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated knowledge of U.S. Food and Drug regulations, as well as of European and international regulatory/industry guidelines/standards, and ability to interpret and apply.
- Some travel may be required.