Site Quality Director - Brookings, South Dakota (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:

Site Quality Director - Brookings, South Dakota (Solventum)

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 a Site Quality Director 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:

• Management Representative with responsibility and authority to ensure Quality Management Systems (QMS) requirements are established, and effectively and efficiently maintained.
• Conducts Operational planning to support the overall Quality strategy for the site and actively participates on the Plant Operating Committee (POC).
• Plans, organizes and directs all quality activities and policies at the site.  Establishing leadership and shared ownership for the Quality Culture within the site.
• Assuring all products released to the market meet their specification and comply with relevant regulatory requirements (medical device and combination products).
• Applying continuous improvement methodology to drive prevention of quality nonconformances and deviations, reduced variation in product and process, improved customer satisfaction, and operational excellence across the site.
• Preparing for, managing, and following-up on quality and regulatory audits/inspections conducted by external agencies, notified bodies, customers, and internal functions.
• Guiding the plant and business with appropriate risk-based decision making around deviations and change control.
• Implementing quality and regulatory strategies aligned to global regulations and business strategic plans.
• Developing the Team to deliver solutions for highly complex and multi-faceted problems, which require ingenuity, creativity, innovation, and strong analytical skills.
• Networking effectively across all business stakeholders and sister plants within the business to share key learnings and capitalize on best practices.

Company Vehicle

This position requires occasionally driving a company vehicle, which will require pre-employment and ongoing review of motor vehicle history for candidates who are offered and hired for this position

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 AND ten (10) years of combined regulatory and/or quality experience within a heath care regulated industry at a private, public, government, or military environment

OR

• High School Diploma/GED AND sixteen (16) years of combined regulatory and/or quality experience within a heath care regulated industry at a private, public, government, or military environment

AND

In addition to the above requirements, the following are also required:

• Six (6) years of leadership experience in the health care industry
• Current, valid Driver’s License

Additional qualifications that could help you succeed even further in this role include:

• Master