Quality Engineer

Full time Quality Engineer II needed in Kettering OH. Company is a global high-tech manufacturing company for the medical device industry; this company has grown 20% over the last 6 years (43% in 2025). Candidates do not have to have Med Device but need to be out of a regulated MFG environments (prior Automotive or Aerospace are encouraged to apply).

75K - 85K with full benefits, some flex for someone more senior.

4-6 years experience preferred.

The Quality Engineer provides customer and factory facing quality support. The position includes managing the interface between the company, its customers and suppliers quality organization, assisting with transition and sustaining of laser manufacturing processes, and support for our quality management system. The Quality Engineer position uses Quality Engineering techniques including:
Problem solving using Lean Six Sigma methodology, Process Validations and Verifications, Process Development and optimization, Gage R&R, and reducing dependence on inspection along with ISO 13485 and/or 21

CFR
820 compliance.

• Liaising with customer quality personnel to resolve issues and Customer Complaints
• Monitoring and disseminating customer quality report cards
• Assisting with troubleshooting of production processes
• Assisting with the PDP process
• Leading development of metrology equipment
• Developing and maintaining quality/control plans
• Developing PFMECAs
• Resolving Corrective and Preventive Actions
• Developing Quality Procedures and conducting training to all personnel as appropriate
• Approving Nonconformance disposition
• Analyzing production and validation data
• Working on continual improvement and process assessment projects as assigned

• Minimum 2 years experience in a Quality Engineering role in a regulated and/or start-up company, or equivalent engineering experience
• Demonstrated technical writing and communication skills. Working knowledge of Statistical software and/or Minitab Bachelor's degree or equivalent experience