Site Quality Director

4 weeks ago

Brookings, South Dakota, United States Solventum Full time
Job Description:

Solventum is seeking a highly skilled Site Quality Director to join our team in Brookings, South Dakota. As a key member of our organization, you will be responsible for ensuring the highest standards of quality management systems (QMS) are established and maintained across our site.

The Impact You'll Make:
  • Management Representative with responsibility and authority to ensure QMS requirements are established and effectively 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 ten (10) 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 sixteen (16) years of combined regulatory and/or quality experience within a healthcare regulated industry at a private, public, government, or military environment.
  • Six (6) years of leadership experience in the healthcare industry.
  • Current, valid Driver's License.
  • Additional qualifications that could help you succeed even further in this role include: Master's degree or higher in a science or engineering discipline, Proven ability to lead cross-functional teams and create excellent collaboration, Proven ability to lead audit/inspection activities, Experience leading continuous improvement projects, Change Management experience of programs with significant strategic importance, Demonstrated skills in customer experience management.
Work Environment:

This position requires occasional 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.

Benefits:

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 $222,044 - $271,387, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience.

In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.).

Additional information is available at: Solventum Global Terms of Use and Privacy Statement.

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 https://www.solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

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