Quality Engineer

Job Title:

Quality Engineer / Quality Compliance Engineer Job Description This role provides cross-divisional quality support for remediation efforts and ongoing compliance across a portfolio of medical device, commodity, over-the-counter drug, and cosmetic products. The Quality Engineer independently establishes, maintains, and upholds quality standards, evaluates production processes, recommends improvements, and manages key quality documentation such as Device Master Records, product specifications, design control files, and CE technical files. This position plays a critical role in ensuring products and processes comply with domestic and international regulations in a highly regulated environment. Responsibilities Provide quality expertise in product development, quality management systems (QMS), design control activities, design history files (DHF), corrective and preventive actions (CAPA), risk management, and CE technical files. Direct and collaborate with supplier representatives to resolve quality issues, ensure implementation of corrective actions (including CAPA and supplier corrective action requests), and contribute to supplier quality improvement programs. Lead supplier qualification activities and support ongoing supplier performance monitoring to ensure consistent quality of incoming materials and components. Lead investigations of product and process non-conformances and out-of-specification results, and develop effective corrective and preventive actions (CAPA) to prevent recurrence. Ensure compliance with domestic and international regulations associated with assigned product lines and processes, including applicable FDA and ISO requirements. Perform quality reviews of design documentation to verify compliance with stated requirements, including vendor quality documents and internal quality records. Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure products meet quality, safety, and functional requirements. Design experiments to identify and understand sources of variation affecting products and processes, and apply statistical process control (SPC) methods to analyze data and evaluate current processes and proposed changes. Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates, including generating and analyzing reports on defective products to identify trends and lead corrective actions. Use concepts of probability and statistical quality control to support data-driven decision-making in process and product quality improvements. Coordinate product testing with internal and external laboratories as required, ensuring timely and accurate test execution and documentation. Build and maintain appropriate product documentation, such as Device Master Records (DMR), in compliance with applicable regulations and internal procedures. Collaborate with regulatory groups and suppliers to support the creation of regulatory submissions, including 510(k) submissions and letters to file, as required. Support remediation efforts across divisions by assessing existing processes and documentation, identifying gaps, and driving corrective actions to strengthen compliance and quality systems. Evaluate production processes and recommend improvements to enhance product quality, reliability, and consistency across medical device, pharmaceutical, and related product lines. Essential Skills 2-5 years of quality engineering experience. Experience in the medical device or pharmaceutical industry. Strong working knowledge of 21 CFR Part 820 and/or

ISO 13485

requirements. Hands-on experience with Device History Files (DHF). Hands-on experience with corrective and preventive actions (CAPA). Experience supporting operations, investigations, and compliance activities in a regulated environment. Demonstrated experience working within a quality management system (QMS). Knowledge of FDA quality system regulations and related regulatory expectations. Ability to interpret and apply domestic and international regulatory requirements to product and process design. Proficiency in designing and executing experiments to investigate process and product variation. Ability to apply statistical process control (SPC) and statistical quality control methods to analyze data and support decisions. Strong documentation skills for generating and maintaining Device Master Records, product specifications, design control files, and CE technical files. Ability to lead investigations of non-conformances and out-of-specification results and to develop robust CAPA solutions. Strong collaboration skills for working with supplier representatives, internal operations, and regulatory teams. Additional Skills & Qualifications Experience with risk management activities related to medical devices and regulated products. Familiarity with CE technical file requirements and supporting documentation for international markets. Experience leading supplier qualifications and participating in supplier quality improvement initiatives. Exposure to process validation, process control, and process improvement methodologies. Experience coordinating testing activities with internal and external laboratories. Experience contributing to regulatory submissions such as 510(k) filings and related documentation. Interest in career growth within a fast-paced and growing organization, with the ability to adapt to evolving responsibilities and projects. Work Environment This position operates in an office-based, hybrid work environment. The role requires on-site presence on Tuesdays, Wednesdays, and Thursdays, with the flexibility to work remotely on Mondays and Fridays. The primary work setting is a professional office, with standard business hours and a focus on collaboration across quality, operations, regulatory, and supplier teams. The position may be based in either a downtown office location or a suburban headquarters, offering a modern office environment that supports both in-person and remote work. The culture emphasizes growth and advancement opportunities, with a busy and expanding operation that provides significant potential for professional development. Job Type & Location This is a Contract position based out of Mundelein, IL. Pay and Benefits The pay range for this position is $45.00 - $45.00/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 hybrid position in Mundelein,IL.

Application Deadline This position is anticipated to close on May 21, 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.