Regional Director QM/ESG/PMO
Medartis develops, manufactures and distributes titanium screws and plates, surgical instruments and system solutions for fracture fixation. We place the highest priority on maintaining stringent quality standards, continuous further development and innovation as well as comprehensive service provision for physicians, staff and patients.
The Regional Director QM/ESG/PMO will be responsible to lead and the development of an agile and lean US Quality Management System with a focus on decision-making for the company and providing strategic input to Senior Management. This individual would oversee all activities related to Quality Management System and Quality Compliance to improve and maintain the overall compliance of the company's medical devices. They will develop and maintain the Medartis business process landscape (eqms) with the goal of building agile and robust business processes together with the cross-functional process owners as a basis for the growth of Medartis in the USA. This individual would maintain close contact with the Regulatory Affairs department and the Global Quality Management System Group to align US QMS within the Medartis family.
Along with the above responsibilities, this role would be responsible for the Sustainability Management (ESG) and Global Project Management Office (PMO) as the main local contact for these areas. This role would lead the local functional multi-project management for all projects in the COO's area of responsibility.
After appropriate induction into the area of responsibility of the QM system of Medartis Inc.(4-6 months) this role will take over the responsibility for the quality management for the region LATAM in particular the direct reports of the QM managers of our sales & supply subsidiaries in Brazil and Mexico.
The Regional Director QM/ESG/PMO will be responsible to lead and the development of an agile and lean US Quality Management System with a focus on decision-making for the company and providing strategic input to Senior Management. This individual would oversee all activities related to Quality Management System and Quality Compliance to improve and maintain the overall compliance of the company's medical devices. They will develop and maintain the Medartis business process landscape (eqms) with the goal of building agile and robust business processes together with the cross-functional process owners as a basis for the growth of Medartis in the USA. This individual would maintain close contact with the Regulatory Affairs department and the Global Quality Management System Group to align US QMS within the Medartis family.
Along with the above responsibilities, this role would be responsible for the Sustainability Management (ESG) and Global Project Management Office (PMO) as the main local contact for these areas. This role would lead the local functional multi-project management for all projects in the COO's area of responsibility.
After appropriate induction into the area of responsibility of the QM system of Medartis Inc.(4-6 months) this role will take over the responsibility for the quality management for the region LATAM in particular the direct reports of the QM managers of our sales & supply subsidiaries in Brazil and Mexico.
Your responsibilities
- Management Representative for the registered site
- Lead FDA Inspections
- Manage ISO 13485 Inspections
- Oversees Quality Management to ensure the company maintains compliance with the FDA Quality System Regulations, the ISO 13485 standard, any country specific regulations and requirements as needed by the business
- Responsible for the business process orientation of the Medartis US "QM" area based on formulated target states in the sense of rolling 3-year plans. Initiation, implementation, coaching and controlling of specific projects that support the development of an business process oriented QM System
- Responsible for the operational management of the "QM System based on defined key figures, standardized processes and targeted team development. Participates in the development and preparation of short-term and long-range plans and budgets based upon broad Company goals and objectives
- Responsible to develop and Maintain all relevant Quality Management Metrics
- Responsible to develop and maintain a Best in Class Deviation Management / CAPA and Change Management process
- Ensures that all activities and operations are performed in compliance with local, state, and federal regulations and laws governing business operations
- Actively supports the maintenance, further development and local implementation of global quality management. Takes on or participates in global strategic quality management projects and programs (QM/RA planning and future road mapping)
- Supporting global PMO and ESG activities
Your qualifications
- 5+ years’ experience in Quality Assurance with a minimum of 6 years in a leadership role in Medical Device
- Bachelor of Science in Business or Technology relevant to the medical device industry. MS degree preferred
- In-depth knowledge of an FDA regulated quality system, ISO 13845 standard, and other country specific medical device regulations
- Exceptional communication skills
- Lean, agile and operational execution skills (Make it Happen)
- Results-oriented, strategic thinker and planner
What we offer
This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company. We look forward to receiving your complete application.
For further information please visit our Website www.medartis.com.
We look forward to receiving your complete online application.
We look forward to receiving your complete online application.
