Director, Medical Surgical International Plant Quality f/m/x

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:

/
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.

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 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.
  

• Collaborating with other functions and providing influential peer leadership 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

• Providing strategic guidance to internal organizations and partners 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

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

• 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

• Proven, 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

Work location:

• 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.
, H1B status).

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.