Senior Design Quality Engineer

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.

Benefits:

• Health Insurance
• Dental & Vision Insurance
• Stock Options
• Paid Time Off
• Flextime