SOLVENTUM · 2 months ago
Site Quality Director (Onsite - Brookings, SD)
Brookings, SD
Full-time
Onsite
Director/Executive
$222K/yr - $271K/yr
12+ years expSolventum is a new company focused on enabling better healthcare solutions through innovation and technology. As a Site Quality Director, you will ensure the establishment and maintenance of Quality Management Systems, oversee quality activities, and lead continuous improvement initiatives to enhance product quality and compliance with regulatory standards.
Business Consulting and Services
No H1B
Responsibilities
Serving as Management Representative with responsibility and authority for ensuring Quality Management Systems (QMS) requirements are established, and effectively and efficiently maintained
Conducting operational planning to support the overall Quality strategy for the site and participating actively on the Plant Operating Committee (POC)
Planning, organizing, and directing 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 specifications and comply with relevant regulatory requirements (medical device and combination products)
Applying continuous improvement methodology to drive prevention of nonconformances and deviations, reduce variation in product and process, improve customer satisfaction, and achieve 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 with global regulations and business strategic plans
Developing the team to deliver solutions for highly complex and multi-faceted problems requiring 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
Qualification
Required
Bachelor's degree or higher a science or engineering discipline (completed and verified prior to start) from an accredited institution AND twelve (12) years of combined experience in regulatory, quality, laboratory and/or manufacturing within a healthcare-regulated industry in a private, public, government, or military environment
Eight (8) years of people management experience
Leadership experience in a Quality role within the healthcare industry
Current, valid Driver's License
Preferred
Proven ability to lead audit/inspection activities
Previous experience as a Management Representative for ISO 13485
Demonstrated competency at root cause problem solving and use of statistics
Proven ability to lead cross-functional teams and create excellent collaboration
Change Management experience of programs with significant strategic importance
Benefits
Medical
Dental & Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Voluntary Benefits
Paid Absences
Retirement Benefits
Company
SOLVENTUM
Gutachter & Abwicklungspartner für Insolvenzverwalter, Steuerberater, Wirtschaftsprüfer, KMU, Banken, Leasinggesellschaften.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase