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.
