Supplier Development Quality Specialist (Remote - United States)

SOLVENTUM

3d • Remote

About The Position

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 Supplier Development Quality Specialist, 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: Providing Supplier Quality Engineering support to manufacturing site and product portfolio teams by actively applying skills from the Quality Body-of-Knowledge for supplier controls related to components and materials used in medical devices, drug/device combination products, other regulated products, and purchased finished goods Identifying and leading improvement opportunities to proactively ensure vendor compliance to all applicable internal, domestic, and international quality regulations, including but not limited to US 21 CFR 210, 211, and 820, ISO 13485, ISO 14971, EU MDR, etc. Executing global internal supplier quality projects and partnering with our vendors to reduce risk, improve processes, and reduce waste using the quality improvement tools of process control & monitoring, DOE, risk analysis, problem solving processes, protocol development, reporting, trend analysis and reaction, capability analysis and measurement system analysis Driving completion of key Supplier Quality requirements including, but not limited to, Supplier Qualifications, Supplier Quality Agreements, Supplier Corrective Action Requests (SCARs), Supplier Change Notice evaluations, Supplier Scorecards, Receiving Material Inspection Plans, and Internal & External Audit Support (to include Supplier assessment/auditing) Maintaining effective Quality Metric performance by identifying and executing activities to enhance purchased material quality, reduce supplied material variances, and resolve decreases in performance. Assuming responsibility of quality programs of major importance to division interests involving scientific research/understanding, applied technology, and product or process innovations. Maintaining a flow of major quality contributions such as material/product/process and system innovations and understandings, and documents and communicates these learnings via internal reports, technical presentations and/or publications.

Requirements

• Bachelor’s degree or higher (completed and verified prior to start) AND eight (8) years of experience in Quality, Continuous Improvement, or Operations/Supply Chain functions in the Medical Device/Pharmaceutical/Aerospace industry in a private, public, government or military environment OR High School Diploma/GED AND twelve (12) years of experience in Quality, Continuous Improvement, or Operations/Supply Chain functions in the Medical Device/Pharmaceutical/Aerospace industry in a private, public, government or military environment
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

• Three (3) years of Supplier and/or Quality-specific Medical Device, Pharmaceutical, or Combination Product experience in a private, public, government or military environment
• Skills including, but not limited to, Supplier Quality Management, Risk Management, Medical Device Manufacturing, Supplier Corrective Action Requests, and Continuous Process & Product Improvement
• Demonstrated successful organizational influence in areas including, but not limited to, compliance excellence, continuous improvement, product-related risk analysis/mitigation, and/or manufacturing process capability and control enhancement (P&PC)
• Strong verbal and written communication skills with the ability to provide diligent, concise, and fact-based communication to Executive Management, Leadership, and cross-functional partners
• Strong decision-making, problem-solving, and continuous improvement skills with the demonstrated ability to create momentum and deliver results in a timely manner by prioritizing personal workloads independently with minimal guidance

Responsibilities

• Providing Supplier Quality Engineering support to manufacturing site and product portfolio teams by actively applying skills from the Quality Body-of-Knowledge for supplier controls related to components and materials used in medical devices, drug/device combination products, other regulated products, and purchased finished goods
• Identifying and leading improvement opportunities to proactively ensure vendor compliance to all applicable internal, domestic, and international quality regulations, including but not limited to US 21 CFR 210, 211, and 820, ISO 13485, ISO 14971, EU MDR, etc.
• Executing global internal supplier quality projects and partnering with our vendors to reduce risk, improve processes, and reduce waste using the quality improvement tools of process control & monitoring, DOE, risk analysis, problem solving processes, protocol development, reporting, trend analysis and reaction, capability analysis and measurement system analysis
• Driving completion of key Supplier Quality requirements including, but not limited to, Supplier Qualifications, Supplier Quality Agreements, Supplier Corrective Action Requests (SCARs), Supplier Change Notice evaluations, Supplier Scorecards, Receiving Material Inspection Plans, and Internal & External Audit Support (to include Supplier assessment/auditing)
• Maintaining effective Quality Metric performance by identifying and executing activities to enhance purchased material quality, reduce supplied material variances, and resolve decreases in performance.
• Assuming responsibility of quality programs of major importance to division interests involving scientific research/understanding, applied technology, and product or process innovations.
• Maintaining a flow of major quality contributions such as material/product/process and system innovations and understandings, and documents and communicates these learnings via internal reports, technical presentations and/or publications.

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.
• Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level