Connecting...

Quality Engineer

My client, a globally recognized Biotechnology company in the Columbus area, is seeking a Quality Engineer to join their team. This Quality Engineer position will be a 6 month contract to hire and can pay between $45-$55 per hour based on prior levels of industry experience.

As a Quality Engineer this individual would be responsible for developing and maintaining quality system documentation as well as technical quality activities for product maintenance, distribution and manufacturing through the application of quality engineering skills for medical device.

The most desirable candidates for the Quality Engineer position will possess the following qualifications:

  • Experience within IVD (In Vitro Diagnostics)
  • Experience developing & maintaining QMS documentation
  • Extensive experience with CAPAs and Risk Analysis activities
  • Knowledge of ISO 14971: 2012, ISO 13485: 2016, & 21 CFR Part 820
  • Certified Quality Engineer (preferred)

As the Quality Engineer, this candidate would be responsible for:

  • Conducting investigations for complaints, CAPAs, production, material and process changes and non-conformances.
  • Write and coordinate efforts for the development and implementation of new and updated Quality System procedures.
  • Conduct statistical analysis and generate trends reports for quality sub-systems
  • Conduct supplier quality audits and develop subsequent preventive action programs
  • Conduct process FMEAs for new processes; maintain and update risk management files
  • Analyzes production quality data to identify trends or issues requirement action or CAPA activity.

Overall, this is a wonderful opportunity to join a company with exciting growth plans, and take on a role that will offer unlimited growth potential and upward mobility. This person will join a fun team in a great environment, and will be able to work on innovative products.

The Hiring Manager is looking to conduct interviews ASAP. If you are interested, a prompt response is encouraged. Please forward your resume and/or contact me directly.

Sthree US is acting as an Employment Business in relation to this vacancy.