Design Assurance Quality Manager

Design Assurance Quality Manager

We are seeking an experienced Design Quality Assurance Manager to lead quality strategy for Class II and III medical device development and manufacturing. This role requires ownership of design quality assurance, regulatory compliance, and continuous improvement while managing a multi-disciplinary quality team. You will collaborate closely with R&D, Manufacturing, and Regulatory Affairs to ensure products are compliant, audit-ready, and 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, audit-ready design history files.
• Drive investigations into nonconformances, deviations, and out-of-tolerance results; lead root cause analysis and corrective/preventive actions.
• Partner with R&D, Manufacturing, and Regulatory Affairs to ensure products meet the highest standards of patient safety and compliance.

Essential Skills

• Bachelor's degree in Engineering or a related technical field.
• 5+ years of experience in medical device quality management.
• 3+ years of experience managing 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.

Additional Skills & Qualifications

• Experience with Class II / Class III medical devices.
• 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 is preferred.

Work Environment

This position operates in a regulated medical device manufacturing and development environment. It requires onsite presence due to inspection, manufacturing, and team leadership responsibilities. The role requires adherence to quality system, documentation, and audit protocols.

Job Type & Location

This is a Contract 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

This is a fully onsite position in Longmont, CO.

Application Deadline

This position is anticipated to close on Apr 30, 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.