Quality Engineer

Quality Engineer

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.

Design & Development Support

• 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.

Quality Management System (QMS)

• 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.

Supplier Quality

• 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).

Manufacturing Quality & Inspection

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $90000.00 - $120000.00/yr. HEALTH / DENTAL / VISION / PAID TIME OFF / HOLIDAY

Workplace Type

This is a fully onsite position in Sunrise,FL.

Application Deadline

This position is anticipated to close on Aug 14, 2026.

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 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 ClearlyRated 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 View email address on click.appcast.io for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.