Sr. Quality Assurance Engineer

Job Title

Responsibilities Oversee the creation, maintenance, and review of DHFs to ensure completeness, accuracy, and compliance with regulatory standards. Ensure all DHF documentation is current and reflects the product's design and development status. Provide guidance and approval for design control documents, ensuring all design inputs, outputs, verifications, validations, and changes are properly documented and meet regulatory requirements. Collaborate with cross-functional teams to integrate design control activities into the product development lifecycle. Sign off on appropriate design control files as an independent reviewer when needed. Review and govern the design transfer process, ensuring accurate communication and documentation from development to manufacturing. Contribute to the assembly, maintenance, and tracking of Design History Files, ensuring they are managed and filed consistently in the QMS system across the organization. Provide guidance and training to the R&D and Quality team regarding DHF procedures and best practices. Govern the design change process and documentation, ensuring compliance with procedures.

Essential Skills At least four years of experience in Design History File creation and oversight. Proficiency with medical device requirements (Class I-II), 510k process, design controls, design change, design transfer, and assessment of risk.

Pay and Benefits The pay range for this position is $45.00 - $55.00/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 Sep 4, 2025.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.