What you want to know:
- Work with one of the leaders in Healthcare Additive Manufacturing
- You will manage an international, talented team
- Develop and execute quality strategies in relation to ISO, MDSAP, MDR, AS/EN as well as FDA and MDR systems
- Great Base Salary, Quarterly Commission, Paid Leave, 401(k), Health and Wellness Plans
- 25% travel including international
Brief Overview:
The Quality Director will develop and enhance our comprehensive healthcare quality strategy while ensuring customer satisfaction and corporate goals are consistently achieved or exceeded. This role also serves the needs of industrial manufacturing and requires dynamic collaboration across Advanced Manufacturing, Personalized Health Services, Medical Devices, and the Application Innovation Group. The role partners Quality leaders, Manufacturing Engineering, Production staff for healthcare and industrial products, and our Regulatory team to promote and deliver clear alignment across the organization. You'll define an innovative quality roadmap that simultaneously improves customer satisfaction, employee engagement, and stakeholder value while serving as a transformational change agent. Join us in shaping the future of manufacturing and making a meaningful impact on additive manufacturing innovation at one of the industry's most forward-thinking companies!
Requirements and experience - Brief overview - after a discussion you will receive the full description:
- Lead and mentor Quality Teams in US and in Europe
- Direct quality management systems activities across all sites
- Ensure regulatory compliance: FDA (21 CFR Part 820), ISO 13485, ISO 9001, MDSAP, MDR, AS/EN 9001, ISO 14971, CAPA
- Lead Strategic Quality Initiatives
- 10+ years experience
- Medical Device, Regulatory and NPI experience
- TQM
