Develop quality assurance documentation to support regulatory submissions
Work with complaint investigators to complete post-market health risk assessments
Participate in resolving nonconformities and corrective/preventive actions (CAPA)
Support design and development of robotic systems, software and instruments.
Develops Quality Assurance Plans for new products.
Contribute to risk management activities for robotics by developing risk management plans/reports, conducting risk reviews, verifying implementation and effectiveness of risk controls and driving post market activities.
Participate in design reviews by identifying design weaknesses and risks associated with the product use and tracking the mitigation of those issues throughout the development process.
Partner with engineering to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria. Promote efficient testing practices.
Complete or contribute to the completion of final design verification and design validation test reports by providing clear concise conclusions with statistical validity and graphical support when necessary.
Utilize standard statistical analysis and problem solving techniques as necessary to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
Identify supplier assessment requirements and communicate these to the supplier quality group.
Evaluate product design changes for verification and validation requirements and assist in change implementation.
0+ years of experience as a Quality Engineer (QE) in a regulated design environment. Prefer experience with medical device product development life cycle, including risk management and design/ process verification & validation
Knowledge of FDA QSRs, ISO 13485 Design Control Procedures and ISO 14971
Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poka Yoke.
Demonstrated ability to effectively work cross functionally with other departments including Advanced Operations, Product Development, Regulatory and Marketing.
Computer proficiency with Mini-tab or similar analysis program, Visio, MS Office.