Director of Quality

A medical device client in Maryland is looking to add to their leadership team! This Head of Quality will be responsible for planning, organizing, and leading the organization’s Quality strategy to ensure the timely delivery of safe and effective products that meet all regulatory and compliance requirements. The role ensures that Quality Management System (QMS) processes are effectively established, implemented, and maintained, while also driving continuous improvement initiatives in compliance with 21 CFR Parts 820 (Medical Devices) and 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products), as well as applicable international standards. The Head of Quality will lead the Quality team and collaborate with cross-functional partners—including Operations, R&D, and Regulatory Affairs—to support business growth and execute strategic initiatives across current and future product platforms.

Duties & Responsibilities

• Serve as the senior Quality and business leader within the organization.
• Understand overall business strategy and proactively align quality systems and initiatives to support company goals.
• Lead Quality Assurance activities related to Operations, Quality Systems, and Quality Engineering.
• Build and lead a high-performing Quality organization, including overseeing teams in Gaithersburg, MD and Roswell, GA.
• Travel to the Roswell, GA facility as needed to support quality team development and site leadership.
• Establish and maintain quality systems that comply with regulatory requirements including FDA QSR (21 CFR 820 and 1271), ISO 13485, CMDCAS, and other applicable standards.
• Ensure quality and compliance standards are consistently met across all operations.
• Provide regular updates to senior leadership regarding quality system performance using established metrics and reporting tools.
• Participate in or lead cross-functional teams to support new product development or resolve complex product quality issues.
• Represent the organization in audits, inspections, field actions, and other regulatory engagements with FDA, notified bodies, and international authorities.
• Collaborate with external partners, vendors, and consultants on quality priorities, validations, and process improvements.

Must Haves:

• Bachelor’s degree in a scientific discipline required.
• Minimum of 5 years in a quality leadership role in FDA- and ISO-regulated environments.
• Extensive knowledge of 21 CFR Parts 820 and 1271.
• Strong background in the healthcare industry (medical device, pharmaceutical), with experience in both Commercial and R&D/Product Development settings.
• Experience with combination products (device/drug) is a plus.
• Proven success in quality system and business process improvement initiatives.
• Experience managing Quality Control (QC) labs, including analytical testing and environmental monitoring, is a plus.
• Deep understanding of FDA and ISO 13485 quality system requirements.
• Experience interacting with government and accreditation bodies (FDA, ISO, AATB), including managing audits and supporting regulatory documentation.
• Strong leadership skills with the ability to define, communicate, and achieve strategic and operational goals.
• Excellent organizational skills with the ability to manage multiple priorities and deliver on tight deadlines.
• Exceptional decision-making and problem-solving abilities.
• Strong interpersonal and communication skills; ability to work effectively with cross-functional teams.
• Proven ability to recruit, lead, and develop high-performing Quality teams.
• Hands-on experience with analytical testing methodologies (e.g., HPLC, MS, GCMS, UV-Vis, NMR), including result interpretation and troubleshooting.
• ASQ Certified Quality Engineer (CQE) or ASQ Certified Quality Auditor (CQA) preferred but not required

Salary of $150-220K annually - depending on experience