Staff QMS Specialist

What you will do:

Will work within the QMS team, under minimal supervision, with responsibility to ensure an effective and efficient quality management system is built and maintained, which includes, but not limited to the following:

• Ensure the Quality Management System is in compliance with the appropriate internal & external regulatory requirements, (including but not limited to FGO, Division, Corporate, FDA, ISO, MDR, and individual country regulatory requirements)
• May act as designee for Management Representative and QMS Manager in appropriate situations.
• Develop optimum future state of QMS for business need, aligned with Corporate, divisional & GQO QMS.
• Identifies improvements & inputs into the quality planning process.
• Drive development and/or modification of Stryker's regional/local Quality Management Systems.
• Manage & Co-ordinate Management Review Process and FGO Audit Program.
• Assess & Quantify requirements for support of QMS to optimum structure under which the service required will be provided.
• Be a key driver of 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 & lead conversations with notified bodies to manage certification changes.
• Ensure QMS reflects actual activities and business needs, and supports NPD  requirements as required
• In a project environment, lead and execute development and/or modification of Stryker's regional/local Quality Management Systems.
• Represents the business during audits to discuss system functionality.
• Is responsible for assessment and approval of change control of the system (BPO/QA approval) per regulatory and internal system requirements

What you will need:

• Bachelor degree/ Masters of Science, Engineering or equivalent/ related subject required,

       and

• Minimum of 4 years in role exposed to Quality Management Systems
• Minimum of 4 years in Quality/Regulatory Affairs environment.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) is desirable.
• Thorough knowledge and understanding of US and International Medical Device Regulations.
• Strong knowledge of Quality Systems (e.​g.​ CA​PA, Audits, Management review, Quality Planning).
• Lead Auditor Qualification is preferred