Quality Engineer

Job Title:

Senior Quality Engineer Job Description This Senior Quality Engineer role leads quality systems, regulatory compliance, and design control activities for Class II and Class III medical devices in a highly regulated environment. You will own CAPA programs, quality investigations, and audit readiness while partnering closely with R D, manufacturing, and operations to ensure products meet ISO and FDA requirements. The position offers high visibility, significant ownership over quality systems and design controls, and the opportunity to drive process improvements and lean initiatives that directly impact patient safety and product performance. Responsibilities Lead and manage CAPA activities, including nonconformance investigations, root cause analysis, and implementation of effective corrective and preventive actions. Ensure ongoing compliance with ISO standards and FDA Quality System Regulations (21 CFR 820) across Class II and Class III medical device manufacturing. Support and lead internal and external audits, including preparation, execution, response to findings, and follow-up on corrective actions. Own and maintain design history files (DHF), including updates, remediation efforts, and documentation of design and change reviews. Drive design control and change control activities to ensure product changes are properly evaluated, documented, verified, and validated. Develop, implement, and improve quality system procedures, standard operating procedures (SOPs), and quality metrics to strengthen overall quality performance. Support process validation activities and collaborate with cross-functional teams to ensure manufacturing processes are capable, controlled, and compliant. Partner with R D, operations, and manufacturing teams to embed quality and compliance into new product development and existing product support. Contribute to lean manufacturing and continuous improvement initiatives focused on reducing defects, improving efficiency, and enhancing product quality. Participate in or support supplier quality activities, including evaluation of supplier performance and resolution of supplier-related quality issues. Prepare and maintain documentation required for regulatory inspections and audits, ensuring records are accurate, complete, and audit-ready at all times. Provide quality engineering guidance and training to cross-functional teams on CAPA, design controls, investigations, and quality system requirements. Essential Skills Bachelor's degree in Engineering, Science, or a related technical field. At least 5 years of Quality Engineering experience in medical device or pharmaceutical manufacturing. Strong working knowledge of ISO standards and

FDA 21 CFR 820

Quality System Regulations. Proven experience leading CAPA activities, including investigations and root cause analysis. Hands-on experience with design control and change control in a regulated environment. Experience supporting or leading internal and external audits. Ability to interpret and apply regulatory and quality system requirements to day-to-day operations. Strong analytical and problem-solving skills for investigating nonconformances and implementing sustainable corrective actions. Effective communication and collaboration skills to work with R D, operations, and manufacturing teams. Additional Skills & Qualifications Experience working with Class III medical devices. Experience leading or contributing to lean manufacturing or continuous improvement projects. Supplier Quality Engineering experience, including working with external suppliers to resolve quality issues. Background in process validation and statistical analysis. Prior experience interfacing directly with FDA auditors. Ability to influence cross-functional teams and drive quality-focused decision-making. Interest in long-term career growth within a stable, regulated industry focused on life-impacting products. Work Environment This role operates in an onsite manufacturing and quality environment within a regulated medical device facility. You will collaborate closely with cross-functional teams, including R D, operations, and manufacturing, and regularly interact with quality system processes and documentation. The facility is subject to FDA and ISO audits, so maintaining an audit-ready mindset and strong attention to detail is essential. The position involves a mix of desk-based work and time on the production floor, with the ability to sit or stand for extended periods and occasionally lift up to 25 pounds. Job Type & Location This is a Contract to Hire position based out of Longmont, CO. Pay and Benefits The pay range for this position is $47.00 - $57.00/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 29, 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.