Medical Device
Quality Engineer

About The Company

Founded 40 years ago, privately held and ISO certified, our client offers medical device contract manufacturing for the production of single-use disposable medical devices.

They offer a complete line of services to support many different medical product lines leveraging off of three core areas of expertise: R.F. Welding of medical bags, extrusion of medical tubing, and downstream assembly and packaging operations for sub-assemblies and finished medical devices.

Your Unique Role

Join a leader in Med Device Manufacturing to help grow your career as a hands-on Quality Engineer.

Reporting to the Director of Quality, you will provide high level hands-on guidance in operational, managerial, and engineering activities to ensure that the quality of the products and the services are achieved, maintained, and improved.

  • Involved in high level participation in New Product Development working closely with cross functional teams, including product development, product management and production, to identify and mitigate quality risk
  • Establish quality standards for products and processes and suggest modifications meant to prevent defects in components or final products.
  • Assist with process validation; process capabilities; and process improvements.
  • Exercise high level judgment to define manufacturing requirements and processes using Lean Manufacturing concepts.
  • Lead in Customer Complaints including response to communications of actions and updates to CMP processes, product requirements, and procedures.
  • Lead in Corrective and Preventive Action (CAPA) system.

What Is In It For You

  • Bonus
  • World Class Medical Benefits
  • Significant Growth Potential
  • Stable company with tenured workforce

Seeking a Candidate With:

  • B.S. or B.A. Degree in Science-related field, Quality Assurance, Engineering, Mathematics/Statistics or equivalent.
  • Previous Quality Engineering experience in a Med device, or manufacturing environment.
  • Experience with establishing and maintaining Metrics, Key Performance Indicators (KPI) using Statistical Process Control (SPC) charts and control charting concepts useful for Six Sigma Quality Improvement preferred.
  • ASQ CQE Certification (or in process of obtaining) preferred.

Location Information

  • Ormand Beach, FL
  • Just north of Daytona Beach along Florida’s Atlantic Coast, Ormond Beach offers a first-class experience without sacrificing its small-town grace
  • Known for elegant relaxation – though, now, it also allows easy access to busier nearby destinations such as next-door neighbor Daytona Beach or, just more than an hour away- Orlando
  • Year round outdoor activities, a historic downtown with excellent shopping and dining.
Click or drag files to this area to upload. You can upload up to 3 files.
Please only upload .doc, .docx, and .pdf files.

Chris Lincoln

Copyright © KLA Industries 2022

455 Delta Ave. Cincinnati, OH 45226