Ihre Aufgaben
- Represent Quality within the Regional ExCom and act as the primary local representative for Quality matters
- Establish and maintain an effective Regional Quality organization across established Quality functional pillars, ensuring alignment with global objectives
- Serve as the liaison between Global Quality and the Regional organization: "Represent Quality in the Region and the Region in Quality"
- Manage and develop the Regional Quality team to support regional development initiatives, fostering growth and effectiveness
- Develop and execute Quality Plans tailored to regional needs and aligned with global strategic goals
- Conduct and communicate transparent risk assessments for regional development activities, considering Quality, Compliance, Timing, and Funding impacts
- Monitor, analyze, and improve Key Quality and Compliance Indicators for regional entities, including newly acquired ones
- Build and promote a strong Quality culture and mindset across the Region, driving continuous improvement and compliance excellence
- Implement and maintain effective Regional Quality Systems aligned with the Olympus Quality Management System, defining and approving harmonized local variations as necessary
- Collaborate with cross-functional teams, including Operations, R&D, Post Market Quality, Medical Affairs, HR, and Legal, to ensure alignment and seamless integration of Quality strategies across the organization
Supervisor responsibilities:
- Direct management of Directors and Senior Managers responsible for QMS, Document Control, and Field Action execution.
- Dotted line leadership of Executive Directors and Directors from other Quality pillars within the Region
- Build and maintain strong working relationships across the Regional Quality team and within the Global Quality organization
- Define and deliver on regional objectives and KPIs, regularly reviewing and assessing the performance of direct and dotted line reports
- Lead, mentor, and develop the Regional Quality team to enhance capabilities, foster collaboration, and meet organizational goals
Ihre Qualifikationen
- Bachelor's degree or equivalent in Engineering or Physical Science, with an advanced technical degree and MBA preferred
- Minimum of 10 to 12 years of experience in quality management or compliance functions, including 5-7 years of management experience in a global position in a regulated environment in the MedTech industry
- Strong prior experience working within the region to be supported in this role
- Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry, such as: ISO, QSR, GMP, GLP, GCP and HIPAA
- Proven expertise in the design, implementation and measurement of quality systems and metrics
- Experience with durable medical equipment and sterile disposable medical devices within MedTech industry is strongly preferred
- Demonstrated initiative in applying innovative approaches to quality and compliance in a fast-paced, dynamic business environment
- Excellent written and oral communication skills, as well as organizational and project management capabilities
- Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives by applying principles of process excellence
- An "out-of-the-box" strategic thinker with strong leadership abilities
- As a change agent, motivated to drive organizational improvement and challenge the status quo
- Proven experience in initiating, cultivating, and embedding cultural change within a complex and diverse organization
- Excellent interpersonal and leadership skills, with an ability to work effectively across diverse cultural environments
- A self-starter who is motivated and capable of inspiring others, demonstrating the highest ethical standards, and actively promoting trust, respect, and integrity both inside and outside the organization
- Focused and target-driven, with a positive, can-do attitude and a commitment to improving both patient experience and company performance
Since this is a regional role within the global team, the individual will be expected to schedule meetings that accommodate multiple time zones. Additionally, up to 25% business travel is required.
Your competencies
The interview will be competence based and the following competencies will be assessed:
•Build for the Future
•Deliver Results
•Lead People
•Lead Self
•Model and champion Our Core Values
Ihre Vorteile
-Flexible working hours, remote work possible (up to 60%)
-30 days of holidays per year
-Modern office and an inspiring working environment
-Employee restaurant with live cooking and healthy food (subsidized)
-Public transport ticket (100 % subsidized) or free parking space
-Company sport groups and an inhouse company gym
-Employee Assistance Program to support your health, mental and emotional well-being
-A comprehensive company pension scheme
-Company medical officer and vaccination offers
-Childcare through our ‘Buttje&Deern’ partner
-Bike leasing