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Quality Engineer
| Hours | Full-time, Part-time |
|---|---|
| Location | Warsaw, IN Warsaw, Indiana |
About this job
Aerotek Engineering is hiring for a Quality Engineer with a large manufacturing company in the Central Indiana area.
This position is responsible for conducting product complaint investigation in compliance with requirements that include FDAs 21 CFR Part 803, 806, and 820 and ISO 13485:2003, and corporate requirements and standards.
Essential Duties and Responsibilities:
1. Conducting product complaint investigations on orthopedic, sports medicine, trauma, extremities, and biologic implant and instruments, and tissue products; coordinating evaluation of returned product, requesting required information, analyzing data, and determining root cause. This includes reviewing surgical techniques to understand product, determining next steps in the investigation, summarizing technical information and preparing record for closure.
2. Determine what information is required and complete MDR Decision Trees and other decision trees to assess reportability to FDA and other regulatory bodies.
3. Analyzing complaint and product trend data, and determining appropriate next steps such as corrective action, field action, etc. to address and /or prevent identified issues.
4. Consulting with Biomet subsidiaries and suppliers regarding Complaint and Product Evaluation activities.
5. Providing or assisting in defining and implementing systematic corrective and preventive actions (CAPA).
6. Supporting Health Hazard Evaluation (HHE) investigations.
7. Performing related duties as required.
Qualifications:
1. Strong attention to detail
2. Ability to acquire product knowledge related to medical devices
3. Excellent written and verbal communication skills
4. Problem solving and analytical skills
5. Knowledge of medical product risk management concepts a plus
Education/Experience:
Bachelors Degree in Biomedical or Mechanical Engineering is required
0-2 years of experience through coursework, internship, or other relatable experience
About Aerotek:
Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .
Aerotek is acting as an Employment Agency in relation to this vacancy.
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