Specialist Quality Assurance Engineer

Solventum•San Antonio, TX

21d•Hybrid

About The Position

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we’re committed to protecting your personal information—learn more in our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ Job Description: Specialist Quality Assurance 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 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.

Requirements

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

Nice To Haves

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

Responsibilities

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.