Director of Quality Assurance (Medical Device) - ONSITE in Denver, CO

Our client is a medical device/combination product manufacturer looking for an experienced Director of Quality Assurance to join their dynamic team. You will be overseeing all things Quality at the Manufacturing site.

As Director of Quality Assurance you will be working closely with the executive leadership and must have experience improving quality management systems and processes.

Responsibilities:

• Develop and implement regulatory strategies to ensure compliance with local and international regulations, standards, and guidelines for medical devices.
• Collaborate cross-functionally with R&D, Regulatory, Operations, and other teams to ensure compliance with quality management systems (QMS) and regulatory requirements throughout the product lifecycle.
• Stay up to date with changes and emerging trends in the medical device industry, and proactively communicate relevant updates to internal stakeholders.
• Conduct internal audits, external audits, and risk assessments to maintain compliance with applicable regulations and standards.
• Oversee the development and implementation of effective quality management systems, including design controls, risk management, and CAPA processes.
• Interact with regulatory authorities and notified bodies during inspections, audits, and submissions to ensure successful outcomes.

Requirements:

• Minimum of 10 years of experience in QA within the medical device industry.
• Strong knowledge of FDA regulations (e.g., 21 CFR 820, FDA QSR) and international standards (e.g., ISO 13485, EUMDR).
• Experience in leading and managing regulatory inspections and audits.
• Familiarity with quality management systems, including design controls, risk management, non conformities and CAPA processes.
• Experience leading Quality departments at a medical device/combination product manufacturing site.
• Implemented continuous improvement of quality management systems and risk management tools.
• Knowledge and examples of identifying and strengthening QMS and cGMP.

If you would like to learn more about this Director of Quality Assurance opportunity, apply today or contact me directly on the following:

wjlynch@barringtonjames.com