Your responsibilities: 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
Your qualification 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
Your benefits 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