Quality Engineer; Pre Market

Job Title:

Quality Engineer

The Quality Engineer – Design Controls is entrusted with ensuring that all design and development activities for medical devices comply with applicable regulatory requirements, internal quality standards, and industry best practices. This role involves close collaboration with R&D, Regulatory Affairs, Manufacturing, and Program Management to build robust Design History Files (DHFs), mitigate risk throughout the product lifecycle, and support successful design transfer into manufacturing.

• Lead and support design control activities and ensure compliance with relevant medical device regulations and standards.
• Ensure proper documentation and traceability throughout all phases of product development, including user needs, design inputs, design outputs, verification, validation, and design transfer.
• Own or support the creation and maintenance of DHF documentation, such as Design & Development Plans, Risk Management Files, and Design Reviews.
• Facilitate risk management activities following ISO standards, including hazard identification, design, use, and process risks, and risk/benefit analysis.
• Ensure risks are reduced to acceptable levels and fully documented throughout the development process.
• Work with R&D and engineering teams to ensure design documentation meets quality and regulatory expectations.
• Collaborate with Manufacturing and Operations to support design transfer activities, PFMEA updates, process validation, and quality planning.
• Participate in design and technical reviews, providing quality and regulatory input.
• Review and approve verification and validation protocols and reports to ensure compliance, technical adequacy, and alignment with user needs and design inputs.
• Ensure test methods and acceptance criteria are clearly defined, justified, and validated as applicable.
• Support Engineering Change Orders (ECOs) related to new product development or design modifications.
• Maintain audit-ready documentation and support internal and external inspections, including FDA, Notified Body, and ISO audits.
• Contribute to improvements in design control processes, documentation templates, and risk management practices.
• Identify gaps and propose solutions to strengthen the Quality Management System.

• 5+ years of experience in a relevant field.
• Engineering degree.
• Proficiency in Design Control, Change Control, DHF, and Design Review.
• Experience with Validation, FMEA, and Inspection.
• Strong risk management skills.

• Experience with Verification processes.
• Familiarity with ISO standards.

This is a Contract to Hire position based out of Miami, FL.

The pay range for this position is $48.08 - $55.29/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)

This is a fully onsite position in Miami,FL.

This position is anticipated to close on Mar 6, 2026.

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 actalentaccom for other accommodation options.