Director (m/f/*) of Quality - Dental Business

at  Solventum

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Job Description:
3M Health Care is now Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients’ lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You’ll Make in this Role

As the Director (m/f/*) of Quality for the Dental Solutions Business, 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:

• Serving as the Business unit Quality Management Representative and leading the Business Quality team by providing expert-level Quality function leadership, guidance, and direction to your team on the Quality Body-of-Knowledge for end-to-end product and process quality assurance programs, procedures, and controls from new product development through post-market improvements for medical devices, drug/device combination products, drug products, and purchased finished goods
• Leading the Dental Solutions Quality team by managing the department budget, directly supervising globally located managers and higher-level professionals (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
• 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.
• Providing strategic guidance to internal organizations in the development and implementation of quality and regulatory strategies for regulated medical devices and drugs, while maintaining effective Quality metric performance by defining and executing activities to enhance product quality, reduce process variances, and resolve signals and decreases in performance
• Providing influential peer leadership as part of the Business Operating Committee to drive organizational improvements in compliance, risk management, product and process quality, quality culture, and predictive quality using industry-leading technologies, systems, and improvement tools for process control & monitoring, structured problem solving, and trend analysis with timely and effective signal resolution

Your Skills and Expertise

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) and a profound experience in Medical Device, Pharmaceutical, or Combination Product experience in a Quality function with experience in quality management 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, Competent Authority Interaction and Influence, External Audit Readiness & Management, Medical Device and 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 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 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

Travel: May include up to 25% domestic and international
Supporting Your Well-being
Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
Diversity & Inclusion
(*) We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community.
Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.
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.
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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) and a profound experience in Medical Device, Pharmaceutical, or Combination Product experience in a Quality function with experience in quality management demonstrating team leadership, compliance excellence, value improvement, and risk reductio

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, Competent Authority Interaction and Influence, External Audit Readiness & Management, Medical Device and 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 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 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 other