Design Quality Engineer

Roles & Responsibilities :

• Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements Sustaining engineering quality support.
• Review and approve design documentation including Verification & Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports.
• Support risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting.
• Revise, review and approve verification and validation activities as required.
• Review and approve any required drawing updates, including design impact assessments Review and approve any labeling updates, including design impact assessments.
• Deliverables to be quarterly based on assigned files. Apply statistical methods and design / process excellence tools to support design engineering rationales / memos as required.
• Provide leadership in all areas of the Quality System, including, but not limited to corrective and preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.
• Provide leadership in the understanding of medical device regulations to other disciplines.
• Ability to work in a team setting within Design Quality and cross-functionally is required.
• Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Medical Affairs, Manufacturing, and Marketing.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance always.
• Design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting.
• Review and approve design documentation including Verification & Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports.
• Ability to work in a team setting within Design Quality and cross-functionally
• Provide leadership in all areas of the Quality System, including, but not limited to corrective and preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.