Manager, Quality Management System and Supplier Quality (Remote)

CellCarta•Naperville, IL

1d•Remote

About The Position

The Manager of Quality Management System and Supplier Quality is responsible for leading and supporting the development and sustainability of the Quality Management System (QMS) at CellCarta by harmonizing quality procedures and processes and providing quality data for the Corporate Quality Management Review. This position serves as a leading in classifying and qualifying suppliers used by CellCarta.

Requirements

Minimum of 5 years' industry or related experience
2 years of audit experience
Knowledge and experience with supplier quality systems GCLP and GMP requirements.
Knowledge of ISO13485, ISO15189 framework and CAP/CLIA requirements.
Experience interfacing with suppliers and aligning on a quality agreement framework.
Ability to merge business and compliance needs to achieve effective solutions.
Knowledge of compliance requirements for different stages of development, must have knowledge of applicable global regulations.
Must have demonstrated written and verbal communication skills, including ability to articulate complex quality agreements with clarity.
Excellent project management skills.

Responsibilities

Aid in the development and improvement of harmonized policies, procedures, work instructions to meet site and business needs and to comply with external requirements.
Establish reports to gather and analyze quality data as an input into Corporate Management Review.
Aid in the coordination of document control, including revisions, training assignment, and issuance of corporate procedures and policies.
Supports the Supplier Quality Program by classifying and qualifying suppliers, auditing suppliers, maintaining quality agreements with corporate suppliers, serving as a primary interface with corporate suppliers, maintaining a system for Supplier Corrective Action Requests (SCAR), and maintaining the global approved supplier list and audit schedule.
Aid in the development and execution of an IT third party vendor management program.
Acts as key team member for software development projects, providing support throughout the software development lifecycle (SDLC), including planning, requirements, risk management, design, verification, validation, release, and change management.
Participate with ISO certification audits, ISO-27001, ISO13485.
Serve as a subject matter expert on Quality Management Systems.