Head of Quality

Position Overview

This role is responsible for planning, organizing, and overseeing the organization’s Quality strategy to ensure the timely delivery of safe, effective products that meet all regulatory and compliance requirements. The position will ensure that processes for the Quality Management System (QMS) are effectively established, implemented, and maintained while proactively improving processes to comply with regulatory standards, including 21 CFR Parts 820 (Medical Devices) and 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products).

In this role, you will lead the Quality team and collaborate closely with key stakeholders across Operations, R&D, and Regulatory functions to support the organization in achieving its strategic goals through current and future product platforms.

This position is based on-site at the company’s new Gaithersburg, MD facility.

Essential Duties & Responsibilities:

Oversee Quality Assurance functions related to Operations, Quality Systems, and Quality Engineering activities.

Lead the Quality organization, including building and expanding the Quality team at the Gaithersburg, MD facility and managing the team at the Roswell, GA facility; travel to Roswell, GA as needed.

Establish and maintain quality systems to ensure compliance with regulatory requirements, including FDA QSR (21 CFR 820 and 1271), ISO 13485, CMDCAS, and others as applicable.

Required Qualifications:

Bachelor's degree in a scientific discipline is required.

Minimum of 5 years of management experience in a Quality leadership role within an FDA- and ISO-regulated environment, with specific expertise in 21 CFR Parts 820 and 1271.

Extensive experience in the healthcare industry (medical devices, pharmaceuticals) in both commercial and R&D/product development settings; combination product experience (device/drug) is a plus.

ASQ Certified Quality Engineer (CQE) or ASQ Certified Quality Auditor (CQA) preferred.