Quality Engineer

Job Title:

Quality Engineer - Design Controls (Medical Device)

Position Overview

We are seeking a Quality Engineer with strong Design History File (DHF) experience to support medical device product development. This role partners cross-functionally with R&D, Regulatory, and Manufacturing to ensure robust design controls, complete DHF documentation, and compliance with FDA/ISO requirements throughout the product lifecycle.

This is a high-impact role within a growing medical device organization, with strong visibility across new product development programs.

Key Responsibilities

* Lead and support design control activities in compliance with FDA, ISO 13485, and internal quality standards

* Own and maintain Design History Files (DHF), ensuring completeness, traceability, and audit readiness

* Ensure full traceability from user needs → design inputs → outputs → verification → validation → design transfer

* Partner with R&D to develop and review design documentation, protocols, and reports

* Facilitate and document design reviews, ensuring all deliverables meet regulatory and quality expectations

* Lead risk management activities (ISO 14971), including DFMEA, hazard analysis, and risk/benefit assessments

* Review and approve verification & validation (V&V) protocols and reports for accuracy and compliance

* Support design transfer to manufacturing, including PFMEA updates, process validation, and quality planning

* Manage and support engineering change orders (ECOs) for new and existing products

* Maintain audit-ready documentation and support internal/external audits and inspections

Required Qualifications

* Bachelor's degree in Engineering or related technical field

* 3+ years of quality engineering experience in medical devices or regulated industry

* Strong, hands-on experience with Design Controls and DHF (creation, maintenance, remediation)

* Experience with risk management (ISO 14971) and FMEA methodologies

* Experience reviewing and approving V&V documentation

* Working knowledge of FDA regulations and ISO 13485 requirements

* Experience with change control (ECOs) and design transfer activities

* Strong documentation and traceability skills in an R&D environment

Preferred Experience

* Experience supporting new product development (NPD) programs

* Exposure to process validation and manufacturing transfer

* Proven ability to improve quality systems, processes, or documentation practices

Why This Role

* High visibility across R&D and product development programs

* Opportunity to take ownership of DHF strategy and execution

* Strong growth potential within a profitable and expanding medical device organization

Job Type & Location

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

Pay and Benefits

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)

Workplace Type

This is a fully onsite position in Miami,FL.

Final date to receive applications

This position is anticipated to close on Jun 23, 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 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,…