Design Quality Engineer Position Summary: We are seeking a highly motivated and detail-oriented Design Quality Engineer to join our team in ensuring the highest standards of quality and compliance in the design and development of medical devices. This role will focus heavily on the creation, maintenance, and auditing of Design History Files (DHFs) in accordance with FDA regulations and ISO standards. ________________________________________ Key Responsibilities: • Design History File (DHF) Management: • Lead the development, review, and approval of DHFs for new and existing products. • Ensure DHFs are complete, accurate, and compliant with 21 CFR Part 820 and ISO 13485. • Collaborate with cross-functional teams to gather and document design inputs, outputs, verification, validation, and risk management activities. • Quality Engineering Support: • Provide quality engineering support throughout the product development lifecycle. • Participate in design reviews and ensure quality requirements are integrated into product designs. • Support risk management activities including FMEA and hazard analysis. • Compliance & Auditing: • Prepare for and support internal and external audits related to design controls and DHFs. • Identify gaps in documentation and lead corrective actions to ensure compliance. • Continuous Improvement: • Drive improvements in DHF processes and tools to enhance efficiency and compliance. • Train and mentor engineering teams on DHF best practices and regulatory requirements. ________________________________________ Qualifications: • Bachelor’s degree in Engineering, Biomedical Engineering, or related field. • 3+ years of experience in quality engineering within the medical device industry. • Strong knowledge of FDA Design Control requirements, ISO 13485, and ISO 14971. • Experience with DHF creation and management. • Excellent documentation, organizational, and communication skills. • Proficiency in quality tools such as FMEA, root cause analysis, and CAPA. ________________________________________ Preferred Qualifications: • Experience with electronic DHF systems (eDHF). • Knowledge of EU MDR and other global regulatory requirements. • ASQ Certified Quality Engineer (CQE) or similar certification. Pay and Benefits The pay range for this position is $35.00 - $50.00/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 Largo,FL. Application Deadline This position is anticipated to close on Aug 27, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.