Site Quality Manager

2 days ago

Columbia, South Carolina, United States Solventum Full time
About Solventum

Solventum is a leading healthcare company that enables better, smarter, safer healthcare to improve lives. 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.

Job Description

We are seeking a highly skilled Site Quality Manager to join our team. As a Site Quality Manager, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.

Key Responsibilities
  • 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.
Requirements
  • Bachelor's degree or higher AND seven (7) years of combined regulatory and/or quality experience within a healthcare regulated industry at a private, public, government, or military environment.
  • OR High School Diploma/GED AND fourteen (14) years of combined regulatory and/or quality experience within a healthcare regulated industry at a private, public, government, or military environment.
  • Five (5) years leadership experience in healthcare industry.
  • Current, valid Driver's License.
Additional Information

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.

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.

The expected compensation range for this position is $183,301 - $224,034, which includes base pay plus variable incentive pay, if eligible.

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