Mansfield, MA30+ days ago
Qualifications: • Bachelor's degree in engineering (Electrical/Electronic preferred, others considered Mechanical, Systems, Chemical) • 5 years of experience of working within a medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP • Strong analytical skills and a working knowledge of problem-solving methodologies • Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques • 5 years of experience in a Quality Assurance role for medical device or pharmaceutical product development • Knowledge of industry best practices and advances in Risk Management practices, process, tools and technology • Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making • Demonstrates excellent organizational, verbal and written communication skills • Proficient with the MS Office Suite, and statistical software • Must be able to work independently with minimal supervision • Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives. Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis) • Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes • Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques • Proficiency in Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control • Conducts, and supports the development of test methods in equipment, process, and product qualifications/validations • Support transfer to manufacturing activities both in product development and base business • Contributes to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions • Develop inspection methodology and acceptance criteria for inspection sampling plans • Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc.