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.
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Key Responsibilities:
•\tDesign History File (DHF) Management:
•\tLead the development, review, and approval of DHFs for new and existing products.
•\tEnsure DHFs are complete, accurate, and compliant with 21 CFR Part 820 and ISO 13485.
•\tCollaborate with cross-functional teams to gather and document design inputs, outputs, verification, validation, and risk management activities.
•\tQuality Engineering Support:
•\tProvide quality engineering support throughout the product development lifecycle.
•\tParticipate in design reviews and ensure quality requirements are integrated into product designs.
•\tSupport risk management activities including FMEA and hazard analysis.
•\tCompliance & Auditing:
•\tPrepare for and support internal and external audits related to design controls and DHFs.
•\tIdentify gaps in documentation and lead corrective actions to ensure compliance.
•\tContinuous Improvement:
•\tDrive improvements in DHF processes and tools to enhance efficiency and compliance.
•\tTrain and mentor engineering teams on DHF best practices and regulatory requirements.
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Qualifications:
•\tBachelor’s degree in Engineering, Biomedical Engineering, or related field.
•\t3+ years of experience in quality engineering within the medical device industry.
•\tStrong knowledge of FDA Design Control requirements, ISO 13485, and ISO 14971.
•\tExperience with DHF creation and management.
•\tExcellent documentation, organizational, and communication skills.
•\tProficiency in quality tools such as FMEA, root cause analysis, and CAPA.
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Preferred Qualifications:
•\tExperience with electronic DHF systems (eDHF).
•\tKnowledge of EU MDR and other global regulatory requirements.
•\tASQ 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 for other accommodation options.