Quality Engineer

Job Title: Quality Engineer – Design Controls (Medical Device) 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. 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 Jun 23, 2026. 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. #J-18808-Ljbffr