Vacancy caducado!
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 RoleAs 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 provide diligent, concise, and fact-based communication to Executive Management, cross-functional peers, and your direct report team
Strong leadership, decision-making, problem-solving, continuous improvement, and management skills with the demonstrated ability to create momentum and deliver results in a timely manner by prioritizing personal workloads, as well as providing guidance, direction, and oversight to others
Work location:
Hybrid Eligible
Germany, Ireland, Poland, Japan, or USA-West Coast
Travel: May include up to 35% domestic and/or international travelRelocation Assistance: May be authorizedMust be legally authorized to work in country of employment Supporting Your Well-being 3M offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope. Chat with MaxFor assistance with searching through our current job openings or for more information about all things 3M, visit Max, our virtual recruiting assistant on 3M.com/careers. Our approach to flexibility is called Work Your Way, which puts employees first and drives well-being in ways that enable 3M’s business and performance goals. Our global Work Your Way initiative gives our employees flexibility in where and how their work can be performed, subject at all times to any location-specific rules and policies that may be in place from time to time (more information on such rules/policies can be provided upon request from the relevant in-location HR).Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.3M Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at 3M are conditioned on your acceptance and compliance with these terms.Please access the linked document by clicking here (http://multimedia.3m.com/mws/media/1274940O/3m-jobs-country-data-privacy-statements-external.pdf) , select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the terms.At 3M we apply science in collaborative ways to improve lives daily as our employees connect with customers all around the world. Learn more about 3M's creative solutions to global challenges at www.3M.com or on Twitter @3M or @3MNews.
Vacancy caducado!