Quality Systems Manager

The Quality Systems Manager (QSM) is responsible for establishing, implementing, and maintaining systems to ensure full compliance to FDA QSR (21 CFR 820), applicable ISO 13485 requirements, and other regulations as needed. The QSM is also responsible for the CAPA program, Management Review, Document Control, Corrections and Removal, Customer Complaints, Compliance training, in-coming inspection, and Design Control.

-Will lead and manage the site Management Review, ensuring that any action items are addressed.
-Management Representative per ISO 13485 requirements.
-Manage customer quality audits.
-Manage regulatory agency audits.
-Provides support to new product development teams, to help ensure that new product quality plans and risk management files are appropriately established.
-Designs and develops forms and instructions for recording, evaluating, and reporting quality data and monthly metrics.
-Manages the site CAPA program, working with Operations and Engineering to ensure timely issue resolution and CAPA closure.
-Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.

Perform Supplier Quality Audits as necessary.
Reports verbally and in writing to the Head of Quality and the General Manager monthly metrics, project updates, QA objectives, etc.