Job Description
As the Director of Medical Surgical International Plant Quality, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.
Here, you will make an impact by:
* Leading the Medical Surgical International Plant Quality team by managing department budgets, directly supervising globally located managers (including objective setting and performance management), interpreting industry trends, customer requirements, and business objectives to define guidelines, methods, and priorities, initiating and approving improvement projects to enhance product and process capabilities, and creating solutions for complex and multi-faceted problems.
* Developing and improving the Medical Surgical International Plant Quality team by providing expert-level Quality function leadership, guidance, and direction to your team on the Quality Body-of-Knowledge for manufacturing-related product and process quality assurance programs, procedures, and controls from design transfer through post-market improvements for medical devices, drug/device combination products, and drug products.
* Identifying and leading improvement opportunities to proactively ensure compliance to all applicable internal, domestic, and international quality regulations and competent authority requirements, including but not limited to, US 21 CFR 210, 211, and 820, ISO 13485, ISO 14971, EU MDR, Health Canada, ANVISA, COFEPRIS, MHRA, TGA, NMPA, PMDA, etc.
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
* Bachelor's degree or higher (completed and verified prior to start)
* At least Fifteen (15) years of Medical Device, Pharmaceutical, or Combination Product experience in a Quality function in a private, public, government or military environment, with at least ten (10) years of quality management experience demonstrating team leadership, compliance excellence, value improvement, and risk reduction
Additional qualifications that could help you succeed even further in this role include:
* ASQ Certified Quality Engineer, ASQ Certified Manager of Quality/Organizational Excellence, or Certified Six Sigma Black Belt
* Skills including, but not limited to, Plant-level Quality Management Leadership, Competent Authority Interaction and Influence, External Audit Readiness & Management, Medical Device and/or Drug Manufacturing, Nonconforming Material Control, Customer Interaction and Support, Quality Engineering, Process Validation, Process Control & Monitoring, Risk Reduction, Continuous Process and Product Improvement, International Field Actions & Recalls, and Organizational Leadership
Demonstrated strong experience navigating and leading teams within environments of complexity, transformation, change, and disruption using objective decision-making, problem-solving, continuous improvement, and effective management skills to create momentum and deliver improvements and timely results in a dynamic and fast-moving environment by prioritizing personal workloads, as well as providing guidance, direction, and oversight to others.
The Work Location is Remote - Ireland, Poland, or Germany, Travel may include up to 40% International Relocation Assistance: May be authorized Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1 B status).