Design Quality Engineer
Designation: Design Quality Engineer
POSITION DUTIES & RESPONSIBILITIES:
- Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.
- 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 & 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 at all times.
- Report task progress and status on a weekly basis.
Degree Requirement: Minimum of Bachelor’s degree in Mechanical Engineering or related field