Job Description:

Specialist Quality Assurance Engineer

The Impact You’ll Make in this Role

As a Specialist Quality Assurance 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. In this role, you will be providing support and guidance to new product development teams to assure the quality and reliability of new products as well as support sustaining efforts, maintaining on-market product quality. This position is responsible for ensuring the quality and reliability of newly acquired Solventum Restorative Healing Technologies (RHT) products through the appropriateness of design inputs, adequacy of verification and validation testing, and identification of key quality characteristics for the device.  Additionally, this position is responsible for facilitating the risk management process for new products and ensuring robust risk files for existing products.  Here, you will make an impact by:

• Serve as the Quality/Design Assurance lead and subject matter expert for product Lifecycle Management and Quality Systems for newly acquired Solventum Restorative Healing Technologies products and systems, supporting new product development, sustaining activities
  • Providing medical device quality engineering expertise, including development, execution, and reporting of assigned activities for test method validation, requirements & risk management, design verification and validation, design transfer, and process verification and validation.
  • Leading cross-functional quality activities with project teams and subject matter experts, including Design Verification, Stability, Post-Market Surveillance, Complaint Handling, Usability/Human Factors, Software Quality, Manufacturing Quality, and Supplier Quality.
  • Leading risk management activities in accordance with ISO 14971, including development of risk management plans, risk analyses, and final risk management reports for assigned projects.
  • Developing quality plans for new products by evaluating historical quality data such as complaints, CAPAs, service records, and repair data, and ensure quality objectives are clearly defined and measurable.
  • Reviewing and approving production release documentation, including specifications, drawings, labeling, process validations, and change management records, ensuring critical quality characteristics and inspection requirements are appropriately defined.
  • Partnering with Quality Assurance, Manufacturing Engineering, and Supplier Quality to ensure organizational readiness for new components and assemblies, including clear specifications, qualified inspection and test methods, and availability of appropriate tools and equipment.
  • Lead post-market surveillance and lifecycle quality activities for assigned RHT products by evaluating complaint trends, CAPAs, field performance data, service records, and other quality signals to identify risks and opportunities for continuous improvement.
  • Ensure post-market surveillance findings are appropriately incorporated into risk management files, design changes, quality plans, and product lifecycle decisions in accordance with applicable regulations and quality system requirements.
  • Leading root cause investigations and CAPA problem-solving activities and provide quality input to product development and manufacturing teams as needed.
• Providing QMS process integration support as needed for design and risk files. Serve as a Solventum Quality Systems and Lifecycle Management SME supporting integration of acquired Restorative Healing Technologies quality systems into Solventum processes and procedures
• Mentoring lower-level engineers in technical and professional development and support audit readiness for internal, corporate, notified body, and regulatory inspections, including serving as a technical subject matter expert when needed.

Your Skills and Expertise 
 

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor’s degree or higher in an engineering or science discipline (completed and verified prior to start) AND seven (7) years of design or quality engineering experience in a regulated industry (private, public, government or military)

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

• Master’s degree in Biomedical Engineering, Mechanical Engineering, Chemistry, Materials Science or related discipline from an accredited institution
• Scientific knowledge and experience in product development of medical devices, including knowledge in country-related regulations and standards applicable to medical device compliance, with one or more of the following:
  • International Organization for Standardization (ISO) 13485 Medical devices - Quality Management Systems (QMS)
  • Food and Drug Administration (FDA) Code of Federal Regulations (CFR) 820 Quality Management System Regulation, 820.30 Design Controls, 812 Investigational Device Exemptions (Clinical Study Product)
  • ISO 14971 Application of Risk Management to Medical Devices
  • European Union (EU) Medical Device Directive Regulation 2020
  • International Electrotechnical Commission (IEC) 62366 Application of usability engineering to medical devices
  • ISO 10993 Biological Evaluation of Medical Devices
• American Society for Quality-ASQ™ certification such as Certified Quality Engineer (CQE) or willingness to obtain
• Six Sigma experience and/or certification related to the design and manufacture of new products

Work location:

•  Hybrid Eligible (Job Duties allow for some remote work but require some onsite work at one of the following locations: San Antonio, TX or Eagan, MN)

Travel: May include up to 25% domestic (including St. Louis, MO)/international

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. 

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.  Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.