Senior Quality Engineer

Job Title:

Sr. Quality Engineer Job Description The Sr. Quality Engineer leads quality systems, compliance, and design control activities for Class II and Class III medical devices in a highly regulated environment. This role owns CAPAs, quality investigations, and audits while partnering closely with R D, manufacturing, and operations to ensure regulatory compliance and drive continuous improvement. The position is hands-on, with a strong focus on design control remediation, process validation support, and lean manufacturing initiatives, offering high visibility and meaningful impact on life-changing medical products. Responsibilities Lead and maintain compliance with ISO standards and

FDA 21 CFR 820

Quality System Regulations across Class II and Class III medical device manufacturing. Own and manage CAPA processes, including leading nonconformance investigations, conducting thorough root cause analysis, and implementing effective corrective and preventive actions. Drive and oversee quality investigations to ensure timely resolution, robust documentation, and sustainable improvements to prevent recurrence. Own and maintain Design History Files (DHF), including updates, remediation activities, and comprehensive design and change reviews. Develop, implement, and continuously improve quality system procedures, standard operating procedures (SOPs), and quality metrics to enhance overall quality performance. Support and participate in internal and external audits and inspections, including preparation, execution, response, and follow-up activities. Collaborate cross-functionally with R D, Operations, and Manufacturing to ensure quality and regulatory requirements are integrated into product design, development, and production processes. Provide hands-on support for design control remediation projects and change control processes to ensure compliance throughout the product lifecycle. Support process validation activities and apply statistical analysis to verify and maintain robust manufacturing processes. Contribute to and influence process improvement and lean manufacturing initiatives to increase efficiency, reduce defects, and improve product quality. Engage with supplier quality activities as needed, helping to ensure that supplied components and services meet defined quality standards. Interface with regulatory auditors, including FDA and ISO auditors, by providing clear documentation, responses, and technical explanations when required. Essential Skills Bachelor's degree in Engineering, Science, or a related technical field. 5+ years of Quality Engineering experience in medical device or pharmaceutical manufacturing. Strong working knowledge of ISO quality standards and

FDA 21 CFR 820

Quality System Regulations. Proven experience leading CAPAs, including nonconformance investigations and root cause analysis. Hands-on experience with design control and change control in a regulated environment. Demonstrated ability to develop, implement, and improve quality systems, SOPs, and quality metrics. Experience supporting or leading internal and external quality audits and inspections. Ability to collaborate effectively with cross-functional teams including R D, Operations, and Manufacturing. Strong analytical skills with the ability to interpret data and drive fact-based decisions. Excellent written and verbal communication skills for clear documentation and audit interactions. Additional Skills & Qualifications Experience working with Class III medical devices. Leadership experience in lean manufacturing or continuous improvement projects. Experience in Supplier quality engineering, including oversight of supplier performance and quality. Experience with process validation and statistical analysis methods in manufacturing environments. Prior experience interfacing directly with FDA auditors and responding to regulatory inquiries. Familiarity with life cycle management of Class II and Class III medical devices. Ability to influence stakeholders and drive quality and process improvement initiatives. Strong organizational skills and attention to detail in managing documentation and quality records. Work Environment This role operates in an onsite manufacturing and quality environment within a regulated medical device facility that is subject to FDA and ISO audits. The Quality Engineer works closely with cross-functional teams, including R D, Operations, and Manufacturing, and regularly engages in hands-on activities on the production floor as well as in an office setting. The position may require sitting or standing for extended periods and the ability to lift up to 25 pounds. The environment emphasizes compliance, continuous improvement, and collaboration, offering exposure to advanced medical device technologies and stable, long-term career growth opportunities in a regulated industry. Job Type & Location This is a Contract to Hire position based out of Frederick, CO. Pay and Benefits The pay range for this position is $47.00 - $60.00/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 Frederick,CO.

Application Deadline This position is anticipated to close on May 1, 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.