Product Design Assurance Expert
The Product Design Assurance Expert is responsible for ensuring that new product designs and manufacturing processes meet all relevant safety and efficacy requirements.
This role focuses on quality and risk management throughout the lifecycle of new product development projects, leading to improved product reliability and customer satisfaction.
The individual represents quality interests within project teams, leading quality engineering tasks and risk management activities, including Failure Mode and Effects Analysis (FMEA), Design FMEA, and related documentation.
Main Responsibilities
* Represent quality interests and concerns on project teams, driving collaborative decision-making.
* Lead risk management activities and own Quality Engineering activities for New Product Development (NPD) projects.
* Review design control compliance requirements for NPD projects and all design elements, ensuring adherence to regulatory standards.
* Develop and coordinate FMEA and PFMEA activities, supporting the creation of risk management files and gauge R&R testing.
* Perform DOE's and other statistical analysis to support product and process optimization or resolve causes of process variation.
* Initiate corrective actions as required, improving overall product quality and reducing defects.
* Support assessment of Biocompatibility testing required as per ISO10993 and company procedures, ensuring safe and reliable products for customers.
* Participate in internal audit and supplier audit programs, maintaining high-quality standards throughout the supply chain.
* Risk Management – FMEA, Risk Analysis, Risk Management File, Gauge R&R and Test Method Validation.