Quality Systems Lead

Are you ready for a new challenge, and motivated to make an impact working for a leading manufacturer of specialty products, with well-known brands in both the consumer and commercial markets! If you want to grow your career and fill an important position, then you could be what our client is looking for in their Quality Systems Lead.  You will be responsible for overseeing quality initiatives and ensuring that existing quality processes operate as specified. This position will work with other departments to scope out requirements and manage completion of projects. This position interacts with R&D, Production, Supply Chain, Graphics, Sales, Project Management, Logistics, and Customer Accounts departments. Reports to the Sr QC Manager. Excellent opportunity with a respected and stable company that offers a competitive compensation package.  If this is for you or someone you know, please forward a current resume to tim@pointonerecruiting.com

Responsibilities 

 Inspect quality of finished products

Manage new quality initiatives

Oversee change control process

Coordinate internal and supplier validations

Ensure, along with regulatory personnel, compliance with EPA and FDA requirements

Oversee new Device History Record (DHR) and Product History Report (PHR) creation

Requirements and Experience

Minimum 5 experience in quality control.  

B.S. degree, preferably in technical discipline such as science or engineering. 

The position also requires:

Understanding of ISO 9001 and ISO 13485 requirements

Familiarity with GMP (21 CFR 820) requirements

Strong computer skills

Strong communication skills

Monday-Friday 1st Shift