Lead Senior Quality Engineer

We are seeking an experienced Lead Design Assurance Quality Engineer to spearhead quality strategy for Class II and III medical device development and manufacturing. This role is pivotal in ensuring design quality assurance, regulatory compliance, and continuous improvement while leading a multi-disciplinary quality team. Collaboration with R&D, Manufacturing, and Regulatory Affairs is key to ensure products meet compliance, are audit-ready, and are built 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 both pre- and post-production, ensuring complete and audit-ready design history files.
• Drive investigations into nonconformances, deviations, and out-of-trend 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 design history files.
• Experience leading CAPA, NCR, and root cause investigations.

• Class II / Class III medical device experience.
• Exposure to implantable devices.
• Knowledge of Statistical Process Control (SPC).
• Experience supporting FDA inspections and notified body audits.
• Master’s degree in Engineering or Quality.

This role operates within a regulated medical device manufacturing and development environment. Onsite presence is required due to inspection, manufacturing, and team leadership needs. Adherence to quality system, documentation, and audit protocols is essential. This position offers a high-impact leadership role in life-saving medical devices, with the opportunity to shape quality culture in a growth-focused MedTech organization. Competitive salary with full benefits and 401(k) match is provided, along with visibility and interaction with Senior leadership and regulatory bodies.

Job Type & Location

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

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)

This is a fully onsite position in Longmont,CO.

This position is anticipated to close on May 19, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $53 - $72