General Overview

Functional Area: Operations (OPS)
Career Stream: Quality (QUA)
Role: Manager 2 (MG2)
Job Title: Quality QMS Manager
Job Code: MG2-OPS-QUA
Job Level: Level 10
Direct/Indirect Indicator: Indirect

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

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 communicaiton 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 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.

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.

Physical Demands

Regularly sitting/standing, free to move around.

Occasionally Sustained visual concentration on small areas, such as monitors, screens.

Regularly Sustained visual concentration on numbers, legal documents

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.

Typical Education

Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related technical discipline. An advanced degree (Master's or MBA) is preferred.

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.