Quality Assurance Specialist

7 hours ago

Saint Paul, Minnesota, United States Solventum Full time
Quality Engineer Role at Solventum

Solventum is a leading company in the healthcare industry, and we are seeking a highly skilled Quality Engineer to join our team. As a Quality Engineer at Solventum, you will play a critical role in ensuring the quality and integrity of our medical devices.

Key Responsibilities:
  • Drive existing product quality enhancement through the use of continuous improvement methods and tools, such as Six Sigma, Product and Process Understanding (PPU), Design of Experiments (DOE), Customer Quality Index (CQI), and Quality at the Source.
  • Support and interact with customers through complaint investigations, resolution, and trending.
  • Ensure the commercialized product design intent and product integrity is retained as materials, processes, methods, and specifications change.
  • Support change as it relates to design changes inspired by quality improvement, source of supply changes, or cost reduction efforts.
  • Support New Product Introductions (NPI) through product and process validations, test method development, and risk management.
Requirements:
  • Bachelor's degree or higher in an Engineering or Science discipline (completed and verified prior to start) from an accredited institution AND three (3) years of medical device Quality Engineering experience in a private, public, government, or military environment.

OR

  • High School Diploma/GED from AND (6) years of medical device Quality Engineering experience in a private, public, government, or military environment.

Additional qualifications that could help you succeed in this role include:

  • 3 years of Quality Engineering experience in medical devices.
  • 3 years of experience applying requirements of ISO 13485 and ISO 14971 in a Quality Engineering or regulatory role.
  • Experience planning and executing Corrective and Preventive Action (CAPA) projects in a medical device environment.
  • Experience analyzing data for trends, special causes, and identifying opportunities for improvement.
  • Experience with facilitating PFMECA or DFMECA development.
  • Experience creating and maintaining Risk Management files for medical devices.
  • Experience analyzing data for trends, special causes, and identifying opportunities for improvement.
  • Experience as a manufacturing or quality engineer in a medical device manufacturing facility.

Work Location:

  • Hybrid Eligible (Job Duties allow for some remote work but require travel to Maplewood, MN at least 1 day per week)

Travel: May include up to 10% domestic

Relocation Assistance: May be authorized

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being

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.

Diversity & Inclusion

Solventum is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community.

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