What are the responsibilities and job description for the Quality Engineer position at United Pharma?
Quality Engineer – Manufacturing (Medical Device)
Position: Quality Engineer
Location: Miami, FL
Duration: 6-Month Contract
Start Date: ASAP
Role Overview
Our client is seeking a Quality Engineer to support manufacturing quality operations within a regulated medical device environment. This role focuses on maintaining compliance with FDA regulations and ISO 13485 while supporting day-to-day production, product release, and shipment activities. The ideal candidate is hands-on, collaborative, and comfortable working in a fast-paced manufacturing setting.
Key Responsibilities
- Provide Quality Engineering support to ensure compliance with FDA regulations and ISO 13485 requirements.
- Support manufacturing quality activities related to routine production and product release.
- Review and support disposition of nonconformances, deviations, and quality records.
- Participate in investigations, root cause analysis, and implementation of CAPA.
- Collaborate with Manufacturing, Engineering, and Operations teams to ensure quality requirements are consistently met.
- Support internal audits, inspections, and continuous improvement initiatives.
- Ensure quality documentation and records support compliant product shipment.
Required Qualifications
- Bachelor’s degree in Engineering or a related technical field.
- 0–5 years of Quality Engineering experience (mid-level; senior profiles not desired).
- Experience working in a regulated manufacturing environment.
- Strong documentation, problem-solving, and communication skills.
Preferred Qualifications
- Experience in the medical device industry.
- Familiarity with Arena QMS and/or Jira.
- Exposure to robotic or electromechanical devices.
- Experience working in early-stage or high-growth companies.