Quality Assurance Engineer

Job Title: Quality Assurance Engineer – Design Controls

Job Description

The Quality Engineer – Design Controls ensures that all design and development activities for medical devices comply with applicable regulatory requirements, internal quality standards, and industry best practices. This role partners closely 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. The position offers the opportunity to contribute to ongoing R&D and product development initiatives within a highly profitable medical device group, providing strong potential for career growth.

Responsibilities

• Lead and support design control activities to ensure compliance with relevant medical device regulations, standards, and internal quality procedures.
• Ensure complete and accurate 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, organization, and maintenance of Design History File (DHF) documentation, such as Design and Development Plans, Risk Management Files, and Design Review records.
• Facilitate risk management activities in alignment with applicable ISO standards, including hazard identification, design risk analysis, use-related risk analysis, process risk analysis, and risk–benefit evaluations.
• Ensure that identified risks are reduced to acceptable levels, fully documented, and maintained throughout the development process.
• Work closely with R&D and engineering teams to ensure design documentation meets quality and regulatory expectations and supports safe and effective medical devices.
• Collaborate with Manufacturing and Operations to support design transfer activities, including PFMEA updates, process validation, and quality planning.
• Participate in design and technical reviews, providing quality and regulatory input and ensuring design control deliverables are complete and compliant.
• Review and approve verification and validation (V&V) protocols and reports to confirm compliance, technical adequacy, and alignment with user needs and design inputs.
• Support Engineering Change Orders (ECOs) related to new product development and design modifications, ensuring changes are properly controlled and documented.
• Maintain audit-ready documentation and support internal and external inspections and audits, including those by regulatory authorities and certification bodies.
• Essential Skills
• 3 years of experience in Quality Engineering, preferably within the medical device or other highly regulated industry.
• Proven experience with Design Control activities for medical devices.
• Hands-on experience with Change Control processes, including Engineering Change Orders (ECOs).
• Strong experience with Design History Files (DHF), including creation, maintenance, and audit readiness.
• Practical knowledge of risk management principles and tools as applied to medical devices.
• Experience conducting or participating in Design Reviews and documenting outcomes.
• Experience with verification and validation activities, including reviewing and approving protocols and reports.
• Ability to apply and interpret inspection methods to support product and process verification.
• Familiarity with R&D environments and cross-functional collaboration with engineering, manufacturing, and regulatory teams.
• Understanding of relevant ISO standards and medical device regulations as they relate to design quality, risk management, verification, and validation.
• Strong documentation skills with attention to detail and traceability across the product lifecycle.

Additional Skills & Qualifications

• Bachelor of Science degree in Engineering or a related technical discipline.
• Experience working within a medical device Quality Management System environment.
• Experience facilitating or contributing to FMEA (Design FMEA and Process FMEA) activities.
• Experience in design quality, including design inputs, outputs, verification, validation, and design transfer.
• Experience with process validation and quality planning in support of manufacturing transfer.
• Demonstrated ability to identify process improvements and contribute to continuous improvement initiatives.

Apply to learn more! This position could interview next week!

Job Type & Location

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 May 1, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $48 - $55