Supplier Quality Senior Engineer (Remote - United States)

SOLVENTUM

2d • Remote

About The Position

Supplier Quality Senior Engineer 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 Supplier Quality Senior Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. This role is critical in maintaining the integrity of the Quality of our supplied materials, continuity of our supply chain and ensuring delivery of better, smarter, safer healthcare products to improve patients’ lives.

Requirements

• Bachelor’s Degree or higher (completed and verified prior to start) AND three (3) years of 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

• ASQ Certified Supplier Quality Professional (CSQP) or Certified Quality Engineer (CQE) desired.
• Demonstrated experience with quality management systems or regulatory requirements (ISO 13485, ISO 9001, CRF Part 820, MDSAP)
• Influential in areas including, but not limited to, compliance excellence, continuous improvement, product-related risk mitigation, and/or manufacturing process capability enhancement
• Strong analytical, root-cause analysis, and problem-solving skills.
• Ability to work independently and manage multiple projects simultaneously.
• Proficiency in Microsoft Office Suite and quality management software.
• Keen attention to detail, with the ability to identify small issues that could escalate into larger problems if left unaddressed.

Responsibilities

• Executes cross-functional collaboration & communication: Work closely with internal stakeholders and support suppliers in meeting quality and regulatory requirements 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.
• Supports compliance: Identify improvement opportunities to proactively ensure vendor compliance with 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.
• Leads issue resolution & continuous improvement: Collaborate and partner closely with our suppliers to reduce risk, improve processes, and reduce waste using quality improvement tools of process control & monitoring, DOE, risk analysis, problem solving processes, protocol development, trend analysis and reaction, capability analysis and measurement system analysis.
• Performs supplier qualifications and assessments: Assess new suppliers for suitability and regularly reassess existing suppliers to ensure ongoing compliance and consistent performance through Supplier Qualifications, Supplier Quality Agreements, Supplier Corrective Action Requests (SCARs), Supplier Change Notice evaluations, Supplier Scorecards, and Internal & External Audit Support

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, etc.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees