Quality Engineer

Job Description

We are seeking a dedicated Quality Engineer to ensure that our products meet both internal and external quality standards, such as ISO and FDA 21 CFR Part 820. This role involves creating and implementing inspection plans, investigating quality issues, and leading corrective and preventive actions. The Quality Engineer will support quality systems, manage complaints, inspections, supplier management, and audits, and assist with internal and external regulatory compliance.

Responsibilities

• Ensure products meet internal and external quality standards (e.g., ISO, FDA 21 CFR Part 820).
• Create and implement inspection plans for materials, manufacturing processes, and final products.
• Investigate quality issues and lead corrective/preventive actions (CAPA).
• Support quality systems including complaints, inspections, supplier management, and audits.
• Stay updated with regulatory standards (FDA, ISO, CE Marking) and help ensure product compliance.
• Assist with internal and external audits by maintaining accurate documentation and processes.
• Participate in design reviews and risk assessments to ensure products meet customer and regulatory requirements.
• Review and approve changes and deviations from standard procedures.
• Maintain detailed records of inspections, tests, validations, and CAPA activities.
• Prepare and present quality reports with key metrics and improvement updates.

Essential Skills

• Experience with nonconformances, supplier quality, quality inspection, and time studies.
• Proficiency in FDA, ISO, and 21 CFR Part 820 standards.
• Strong skills in root cause analysis and CAPA.
• Experience with regulatory compliance, design review, and risk assessment.
• Minimum of 2 years of experience.
• Engineering degree.

Additional Skills & Qualifications

• Familiarity with FDA and ISO13485.
• Understanding of 21 CFR Part 820.
• Experience with root cause analysis and CAPAs.
• Regulatory knowledge.
• Participation in design reviews.
• Risk assessment experience.

Work Environment

On Site role. You will join a dynamic and rapidly growing medical device company at the forefront of research and development, crafting devices that significantly improve people's lives.

Pay and Benefits

The pay range for this position is $35.00 - $45.00/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 Miami,FL.

Application Deadline

This position is anticipated to close on Jul 15, 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.

Salary : $35 - $45