Engr Quality

Quality Engineer (Solventum) The 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 provide 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, providing quality engineering services with accountability for development, execution, and reporting of assigned activities such as 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., US Food and Drug Administration inspections), Notified Body audits, and internal/corporate audits; may participate as a technical subject‑matter expert.
• Ensure corporate policies, procedures and security standards are complied with while performing assigned duties.

Bachelor's Degree or higher in Engineering or Engineering Science and at least one year of experience as a Quality Engineer within a medical device organization.

Additional mandatory qualifications:

• One year of experience working under FDA regulations and recognized quality standards, including ISO 14971.
• Must be legally authorized to work in the country of employment without sponsorship for employment visa status (e.g., H1B status).

• Demonstrated experience conducting root cause investigations for medical device, biotechnology, and pharmaceutical products.
• Experience reviewing and approving process validation reports, as well as verification and validation activities.
• Proven ability to review and approve updates to Quality System documentation, Design History Files, and product labeling for new and existing products.

Hybrid Eligible (some remote work; travel to San Antonio, TX at least two days per week).

Travel: 5% domestic and/or international.

May be authorized.

Expected compensation range for this position is $71,200 - $97,900, which includes base pay plus variable incentive pay, if eligible.

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

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.