Lead Senior Quality Engineer

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., * 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.

• 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.

This is a Contract to Hire position based out of Longmont, CO.

Pay and Benefits

The pay range for this position is $53.00 - $72.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - 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)

Workplace Type

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.