Quality Engineer

Job Description:

Quality Engineer / Quality Compliance Engineer 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. 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. Job Type & Location This is a Contract position based out of Glenview, 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 Glenview,IL.

Application Deadline This position is anticipated to close on May 21, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.