What are the responsibilities and job description for the Sr. Director, Design Assurance position at Jobleads-US?
Job Title: Global Design Assurance Leader
Location: Center Valley, Pennsylvania
We are seeking a highly skilled and experienced Global Design Assurance Leader to join our team at Olympus. This role will be responsible for developing and overseeing the global risk management process, collaborating with cross-functional teams to drive product development initiatives, and establishing consistency in design control processes.
Key Responsibilities:
- Oversight of global risk management process, including global harmonization and effective training tools
- Collaboration with CTO organization to develop, deploy, and educate staff on compliant and globally harmonized design control processes
- Establishment of consistency in the application of statistics throughout design control processes and adjacent processes
- Management of governance and operating mechanisms focused on driving product Quality and Compliance objectives
- Oversight of Quality Data and actions to implement improvements across the Olympus product portfolio
Requirements:
- Bachelor's degree or equivalent in a Life Science focus, Engineering, or Physical Science required
- Minimum of 15 to 20 years of experience in quality management or design assurance with at least 5-7 years of management experience in a global position in a regulated environment in the MedTech industry
- Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry
- Demonstrated expertise in the design, implementation, and measurement of quality systems and metrics
About Olympus:
Olympus is a global medical technology company committed to making people's lives healthier, safer, and more fulfilling. We partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis, and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
We Offer:
- Competitive salaries and annual bonus
- 401(k) with company match
- 24/7 Employee Assistance Program
- Free live and on-demand Wellbeing Programs
- Generous Paid Vacation and Sick Time
- Paid Parental Leave and Adoption Assistance
