Senior Quality Engineer

The Mullings Group is partnering with Swan Endo Surgical, a fast-growing surgical robotics company advancing minimally invasive procedures through innovative technology, to find a Design Quality Engineer.

This is a chance to get in early at a surgical robotics company where quality is built into the product from the ground up, not bolted on after the fact. You'll work shoulder to shoulder with engineering, manufacturing, and regulatory teams across the full product lifecycle, from development through manufacturing.

• Developing, maintaining, and continuously improving the QMS in accordance with ISO 13485 and FDA 21 CFR Part 820
• Partnering with engineering to embed quality requirements into design and development, including documentation review and traceability
• Risk management activities including hazard analysis, FMEA, and risk documentation
• Test method development, verification and validation execution, and inspection criteria for product and process qualification
• Supplier qualification and resolution of component and process quality issues
• Design transfer support to ensure products transition to manufacturing with the right quality controls in place

• Bachelor's or Master's in Engineering, Biomedical Engineering, or a related field
• 4 to 7 years of medical device experience with a BS, or 3 to 6 years with an MS
• Working knowledge of ISO 13485, FDA 21 CFR Part 820, and ISO 14971
• Design control and risk management expertise
• Experience with eQMS platforms and requirements management tools

The environment is fast paced and energetic, travel is minimal at under 10%, and you'll report directly to the Head of QA/RA/CA.