Senior Manager, Quality Management Systems

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 Senior Manager, Quality Management Systems is responsible to lead and development an agile and lean US Quality Management System with focus on decision making for the company. Oversees all activities related to Quality Management System and Quality Compliance to improve and maintain the overall compliance of the company's medical devices. Develops and maintains 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. Maintains close contact with the Regulatory Affairs department and the Global Quality Management System Group to align US QMS within the Medartis family.

Your responsibilities

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
Conduct internal Quality and external supplier Audit
Responsible for the Deviation, CAPA and Complaint Handling processes including Post Market Surveillance activities
Ensures that all activities and operations are performed in compliance with local, state, and federal regulations and laws governing business operations
Serve as a team member to provide quality assurance and risk management expertise to product development teams.
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)
Supports Production and Design Quality to be a competent Partner for internal Stakeholder and to ensure a lean, agile and growth supporting Quality Management

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.