Manager, Global QMS

Summary

Responsible for HT quality plan, culture initiatives and monitoring of objectives and KPIs. Own the global QMS training strategy; develop minimal requirements for training, onboarding and refresher training for all HT employees, assign, and track mandatory compliance training to ensure organization-wide competency. Improve and harmonize QMS policies across global sites to ensure consistency in compliance. Oversee the lifecycle of controlled documentation and data integrity. Manage the Corrective and Preventive Action (CAPA) system to ensure systemic issues are identified and closed. Global assessments across sites and management of CAPAs.

Detailed Description

Quality Management System activities to assist in global harmonization implementation to ensure compliance to applicable medical device regulations per jurisdiction, guidance and standards.

Develop and provide training for all HT employees ensuring training and awareness compliance across the HT organization

Ensure fully excution of the Quality Plan and objectives

Lead the HT CAPA process and indicators ensuring compliance across HT facilities.

Lead internal audit programs and lead for external regulatory inspections (FDA, Notified Bodies), lead the inspection readiness program.

Improve HT quality agreement templates and process, support site Quality leaders in negotiations and approval of quality agreements, lead internal supplier agreements across sites

Travel to foreign countries is required, travel requirements greater than 50%. Passport is necessary.

Position requires composure and ability to interface with Director's leadership. Good communication skills are essential

Knowledge/Skills/Competencies

• Education: Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related technical discipline. An advanced degree (Master's or MBA) is preferred.
• Experience: Minimum of 7-10 years of experience in quality assurance/QMS role within the medical device industry, desired experience in a global or multi-site managerial capacity.
• Required experience in Quality System (ISO 13485) applications of medical device manufacturing and/or design; Experience in Direct participation with FDA Inspections. Understanding of the medical device statutes, standards and regulations to discuss, apply and resolve complex issues of compliance with highly educated and professional teams. Able to clearly understand the risks of non-compliance, including patient harm, company sanctions, fines and possible jail.
• Proven track record of successfully leading major regulatory audits (FDA, Notified Bodies) and managing comprehensive QMS integrations.

Skills

• Expert knowledge of ISO 13485, FDA 21 CFR Part 820, Device Regulations (EU MDR) is a plus
• Strong leadership and cross-functional collaboration skills, with the ability to influence global teams.
• Excellent analytical and risk management capabilities (ISO 14971 familiarity is a plus).
• Ability to translate complex regulatory and procedural information into clear, accurate, and accessible documentation.
• Proficiency in developing detailed protocols, such as CAPA reports, non-conformance records, and validation documentation, where technical accuracy is critical to patient safety and product quality.
• Excellent communication skills, both written and verbal, for presenting compliance strategies to senior management.

Typical Experience

• Minimum of 7-10 years of experience in quality assurance/QMS role within the medical device industry, with at least 3 years in a global or multi-site managerial capacity.
• Required experience in Quality System (ISO 13485) applications of medical device manufacturing and/or design; Experience in Direct participation with FDA Inspections. Understanding of the medical device statutes, standards and regulations to discuss, apply and resolve complex issues of complaince with highly educated and professional teams. Able to clearly understand the risks of non-compliance, including patient harm, company sanctions, fines and possible jail.
• Proven track record of successfully leading major regulatory audits (FDA, Notified Bodies) and managing comprehensive QMS integrations.