Senior Engr Quality; Health Care

Senior Quality Engineer Impact You’ll Make in this Role

• Lead the development of process risk management per ISO
  14971 for assigned projects.
• Provide quality engineering services for new and existing medical device products and offer feedback to product development and manufacturing.
• Lead failure investigations and problem resolution.
• Participate in and lead assigned project teams/tasks for the development and support of new and sustaining products and processes by providing quality engineering services to assigned projects with accountability for development, execution, and reporting of assigned activities for test method validation, design and process verification and validation, etc.
• Review and approve updates to quality system documents, quality system documentation, and labeling for new and existing products.
• Mentor lower-level engineers in technical and professional development.
• Review drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing, proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods.
• Facilitate audit functions to support audits by governmental competent authorities (e.g., FDA inspections), Notified Body audits, and internal/corporate audits; may participate in audits as a technical subject-matter expert.

• Bachelor’s Degree or higher in Engineering or Engineering Science and at least 3 years of experience as a Quality Engineer within a medical device organization in a private, public, government, or military environment.
• 1 year of experience working under FDA regulations and recognized quality standards, including ISO 14971.

• Hybrid Eligible: job duties allow some remote work but require travel to San Antonio, TX at least 2 days per week.
• Travel: 5% domestic and/or international.
• Relocation Assistance: may be authorized.

• Expected compensation range: $106,000 - $145,750 (includes base pay plus variable incentive pay, if eligible).
• Benefits include medical, dental and vision, health savings accounts, health care and dependent care flexible spending accounts, disability benefits, life insurance, voluntary benefits, paid absences, and retirement benefits.
• Additional information at:

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.

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