Quality Assurance Coordinator - New York, United States - CalibreScientific Inc

Description

Position Summary:
To ensure compliance through the development, implementation, and maintenance of the Business Unit's Quality System.

This includes electronic and paper-based methods for document control, training, change management, nonconformances, corrective and preventative actions, complaints, and Risk Management.

Additionally, this position upholds the Quality Objectives and KPIs for Calibre Scientific at the Business Unit Level.

Experience within a Medical Device company or ISO 9001/13485 certified company preferred.


Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform the following satisfactorily (other duties may be assigned).

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Review production batch records to ensure that products meet release specifications.
Review, prepare, execute, approve, assist with, and maintain applicable Quality System elements.
Support integration of current and future acquisitions and maintenance of the Quality System into an electronic QMS.
Work cross-functionally to share ideas and drive continuous improvement activities.

Collaboratively negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy through technical support, as needed (e.g., Customer complaints/feedback).

Evaluate monthly trending reports and metrics, as required to support the visibility of the health of the quality management system.

Accountability for Quality System responsibilities (initiate, evaluate/investigate, approve, and retain) which include related Nonconformances, Corrective Action, Preventative Action, Document Control, Change Control, Risk management, Supplier Quality, etc.

Support regulatory authorities' and ISO certification audits.
Update and maintain documentation, as required to ensure quality compliance.
Contribute and lead projects and improvements from Corporate to Business Unit Levels
Support Business Unit processes and projects as agreed with Quality Management and the BU's General Manager.
Additional responsibilities as required by management.