Job Description:
3M is establishing two industry-leading companies, creating value through the spin-off of its Health Care business, while 3M will continue to be a global material science leader, focusing our innovation to win in favorable global megatrends and attractive end markets. This new Health Care Company will be a leading global diversified health technology company with:
- Proven category leadership
- Exposure to attractive end-markets
- Innovation mindset driving improved patient outcomes
- Collaborative customer relationships
- Deep global regulatory experience
- Operational excellence and strong cash flow
- Strong sales growth and profitability with significant recurring sales
We expect the creation of the two companies will be completed by the end of 2023. For now, we will continue to operate as one global company. This role is positioned to drive the success of the "New Health Care Company”.
This position provides an opportunity to transition from other private, public, government or military experience to a 3M career.
The Impact You’ll Make in this Role
As a Director (m/f/*) of International and Distribution 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 International and Distribution Quality team by providing expert-level Quality function leadership, guidance, and direction to your team on the Quality Body-of-Knowledge for post-production quality assurance programs, policies, processes, procedures and controls for medical devices, drug/device combination products, and purchased finished goods
- Identifying and leading improvement opportunities to proactively ensure internal country-level 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.
- Defining and leading global efforts to ensure area and country-level quality system and competent authority compliance for imported products, as well as locally-sourced purchased products, including local QMS deployment, product quality assurance, competent authority interactions, and local language over-labeling and product release
- Partnering with the Operations and Supply Chain organizations to define and implement effective oversight of globally-located internal distribution, service, and repair centers in order to drive quality and compliance, reduce risk, improve processes, and reduce waste using the quality improvement tools of process control & monitoring, structured problem solving, and trend analysis with timely and effective signal resolution
- Defining and implementing appropriate quality management oversight mechanisms for a broad network of 3rd party Distributors who provide a variety of services in countries where an export model is leveraged
Your Skills and Expertise
To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:
- Bachelor’s degree or higher (completed and verified prior to start)
- Ten (10) years of Medical Device, Pharmaceutical, or Combination Product experience in a Quality function in a private, public, government or military environment, with at least 5 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:
- Demonstrated extensive experience in ensuring compliance with multiple International regulatory requirements, with at least five (5) years of Quality Systems and/or Quality Assurance Medical Device, Pharmaceutical, or Combination Product experience in a private, public, government or military environment
- Skills including, but not limited to, Imported Product Country Compliance, Competent Authority Interaction and Influence, External Audit Management, Local Language Product Labeling, Medical Device Manufacturing, Nonconforming Material Control, Customer Interaction and Support, Continuous Process Improvement, International Field Actions & Recalls, and Organizational Leadership
- Demonstrated successful organizational influence in areas including, but not limited to, compliance excellence, continuous improvement, product-related risk mitigation, and process capability and efficiency enhancement
- Strong multilingual (English, German, Spanish, Japanese, and/or Chinese desired) verbal and written communication skills with the ability to provid