Lead Senior Quality Engineer
About the role
We are seeking an experienced Lead Design Assurance Quality Engineer to spearhead quality strategies for Class II and III medical device development and manufacturing. This role entails ownership of design quality assurance, regulatory compliance, and continuous improvement while leading a multi-disciplinary quality team. You will collaborate closely with R&D, Manufacturing, and Regulatory Affairs to ensure products are compliant, audit-ready, and adhere to the highest patient safety standards.
Responsibilities
- Own and maintain compliance to ISO 13485:2016 and FDA 21 CFR Part 820 across development and manufacturing.
- Lead design quality assurance activities pre- and post-production, ensuring complete, audit-ready design history files.
- Drive investigations into nonconformances, deviations, and out-of-tolerance results; lead root cause analysis and corrective/preventive actions.
Essential Skills
- Bachelor's degree in Engineering or related technical field.
- 5+ years in medical device quality management.
- 3+ years managing or leading quality teams.
- Hands-on experience with ISO 13485:2016 and FDA 21 CFR 820.
- Direct ownership of design controls and DHF.
- Experience leading CAPA, NCR, and root cause investigations.
Additional Skills & Qualifications
- Class II / Class III medical device experience.
- Exposure to implantable devices.
- Statistical Process Control (SPC).
- Experience supporting FDA inspections and notified body audits.
- Master's degree in Engineering or Quality.
Work Environment
You will work in a regulated medical device manufacturing and development environment. This role requires onsite presence due to inspection, manufacturing, and team leadership needs. You must adhere to quality system, documentation, and audit protocols.
Job Type & Location
This is a Contract to Hire position based out of Longmont, CO.
Pay
The pay range for this position is $53.00 - $72.00/hr.
Benefits
If eligible, the benefits available for this temporary role may include: Medical, dental & vision; Critical Illness, Accident, and Hospital; 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available; Life Insurance (Voluntary Life & AD&D for the employee and dependents); Short and long-term disability; Health Spending Account (HSA); Transportation benefits; Employee Assistance Program; Time Off/Leave (PTO, Vacation or Sick Leave).