We are seeking to hire a Senior Design Quality Engineer. In this role, you will support the design and development of new medical devices through the application of quality engineering practices and principles. You will have a proven track record of supporting design assurance activities including design controls and risk management in the development of new medical products.
This is a full-time, on-site position.
Responsibilities:
Lead design assurance activities in support of medical device design and development.
Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, and verifying implementation and effectiveness of risk controls.
Responsible for design controls, quality planning, design reviews, test method development, and design verification.
Work with manufacturing engineering to ensure that necessary process controls are in place for design changes.
Monitor compliance with quality procedures and FDA QSRs and ISO standards and guide the team as necessary.
Act as subject matter expert in design controls and risk management processes.
Qualifications:
Bachelor's Degree in a related discipline (e.g. Engineering, Physical or Life Science) with an advanced degree preferred.
Minimum 5 years experience in medical device design quality assurance.
Direct experience in design controls and risk management activities.
Knowledge of FDA regulations and international standards for medical devices is preferred.
Demonstrates strong knowledge of quality engineering principles and best practices.
Certified Quality Engineer (CQE) certification is a plus.