Job Details

• Actively participate on teams to support product development activities.
• Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
• Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
• Develop insights related to customer needs, product risks, and product performance requirements.
• Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
• Partner with R&D to drive safety and performance in new products
• Implement data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
• Ensure effective implementation and compliance to all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.

• Actively participate on teams to support product development activities.
• Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
• Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
• Develop insights related to customer needs, product risks, and product performance requirements.
• Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
• Partner with R&D to drive safety and performance in new products
• Implement data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
• Ensure effective implementation and compliance to all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.

Reference ID - GH/PHL/JC//14052018//75412/Staff Engineer - Quality