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EnsoDataQuality Assurance Engineer
QA Engineer developing E2E automation framework for web and mobile applications in healthcare. Ensuring quality and regulatory compliance in a hybrid work environment.
About the role
- Leading quality planning for critical material redesign or replacement projects for Solventum medical / combination devices.
- Ensuring critical to quality attributes are defined and achieved throughout the projects while maintaining compliance to our quality management system.
- Defining and implementing test methods and test method validation, stability, process validation, updated risk management files, supplier assessments, and material design verification and validation strategies to satisfy design change controls and ensure and improve reliability and capability, while continuing to meet our customers’ expectations of product performance and quality.
- Managing change through the lens of patient safety by assessing its impact on the products’ risk profile.
- Engaging cross-functional team to drive robust risk mitigations.
- Pursuing united goals with cross-functional global teams composed of members from R&D, manufacturing, regulatory, product stewardship, business, clinical, and various other functions.
Requirements
- Bachelor’s Degree or higher (completed and verified prior to start)
- Three (3) years of Medical Device, Pharmaceutical, or Combination Product experience in a Quality or Product Engineering or Design Assurance function in a private, public, government or military environment
- Scientific knowledge and experience in development of medical devices and relevant regulations and standards applicable to medical device compliance, such as ISO 13485 and ISO 14971
- Master’s degree in Chemistry, Biology / Microbiology, Material Science, or related discipline from an accredited institution
- American Society for Quality-ASQ™ certification such as Certified Quality Engineer (CQE)
- Six Sigma experience and/or certification related to the design and manufacture of new products
- Skills include, but are not limited to, Quality Engineering, Design Controls (including Design Verification), Process Validation, Risk Management, Test Method Validation, Critical to Quality (CTQ) Definition & Control, Critical Thinking, Statistical Data Analysis, Continuous Improvement, excellent communication and documentation, and the ability to navigate complexities and create solutions in highly technical and regulated environment.
Benefits
- Medical
- Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
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