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in Lorain, OH

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Hours Full-time, Part-time
Location Lorain, Ohio 44052
Lorain, Ohio

About this job

A large company in the Elyria, OH area is looking for a Biomedical/Quality Engineer to add to their team. This person will be responsible for the following:

  • In charge of CAPAs, running root cause investigations, and making recommending changes
  • Conduct and document product evaluations with input or guidance from Quality & Regulatory Engineering, management with the goal of seeking the underlying cause of the device alleged occurrence
  • Reference applicable product documentation such as specifications, manuals, service requirements, etc.
  • Process quality documentation as applicable to Federal regulations including 21 CFR 820 and in accordance with ISO 13485 and internal Standard Operating Procedures
  • Complete investigations as needed

Requirements:

  • Bachelor's degree in Engineering or Science.
  • One (1) year of engineering, manufacturing or quality experience
  • Knowledge of root cause investigation tools
  • Knowledge of FDA (21CFR 820) and ISO (ISO:13485) regulations preferred




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Aerotek is acting as an Employment Agency in relation to this vacancy.