Quality Engineer

Quality Engineer

Location:

Sunrise, FL Industry: Medical Device Manufacturing Experience Level: Intermediate

Employment Type:

Full-Time Overview We are seeking a Quality Engineer to support the design, development, and manufacturing of Class II medical devices. This individual will play a key role in Design Assurance and Design Control activities throughout the entire product lifecycle, while also supporting supplier quality, inspection, process validation, and Quality Management System (QMS) initiatives. The ideal candidate will combine hands-on quality engineering experience with a strong understanding of medical device regulations, risk management, and manufacturing quality practices.

• Design Assurance & Design Control (Phase I-IV) + Support user needs definition, intended use documentation, feasibility studies, and initial risk assessments.
• + Assist with design input/output documentation, traceability matrices, and design review activities.
• + Ensure compliance with FDA Quality Management System Regulation (QMSR/21 CFR 820) and ISO 13485 requirements throughout product development.
• + Develop and execute verification and validation protocols and reports.
• + Support test method validation, statistical sampling plans, and design risk management activities in accordance with ISO 14971.
• + Assist with design transfer activities and support process validation efforts, including IQ/OQ/PQ.
• + Maintain Design History Files (DHF), Device Master Records (DMR), and risk management documentation.

• + Partner with Engineering and R&D teams to support design changes and Engineering Change Orders (ECOs).
• + Participate in cross-functional design reviews and provide quality and regulatory guidance.
• + Apply risk-based decision-making principles throughout product development.

• + Support implementation and continuous improvement of the Quality Management System.
• + Participate in internal audits and quality system assessments.
• + Assist with CAPA, nonconformance investigations, document control, and quality process improvements.

• + Support supplier qualification and approved supplier management activities.
• + Conduct supplier performance monitoring and participate in supplier audits.
• + Review and help manage Supplier Corrective Action Requests (SCARs).

• + Perform or oversee receiving, in-process, and final inspections.
• + Develop inspection plans, sampling strategies, and acceptance criteria.
• + Utilize measurement and gauging equipment to verify product conformity.
• + Support investigations and disposition activities for nonconforming materials.

• + Bachelor's degree in Engineering or a related technical field.
• + Experience with Design Controls and Design Assurance in a regulated environment.
• + Experience supporting Supplier Quality programs.
• + Hands‑on experience with receiving, in-process, or final inspection activities.
• + Knowledge of FDA-regulated quality systems and medical device product development.

• + Experience with process validation activities, including IQ/OQ/PQ.
• + Experience with CAPA, root cause investigations, and nonconformance management.
• + Knowledge of ISO 13485 and ISO 14971 standards.
• + Experience using statistical analysis tools such as Minitab.
• + Experience with Design of Experiments (DOE) and statistical sampling techniques.
• + Medical device industry experience preferred.

This is a Permanent position based out of Sunrise, FL.

The pay range for this position is $90000.00 - $120000.00/yr.

HEALTH / DENTAL / VISION / PAID TIME OFF / HOLIDAY

This is a fully onsite position in Sunrise,FL.

This position is anticipated to close on Aug 14, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a Clearly Rated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email actalentaccom for other accommodation options.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance…