Senior Manager-Global Quality Systems (Medtech)

Location: On-site in Trumbull, Connecticut, or Livingston, New Jersey, United States; up to 20% domestic or international travel may be required.

Salary: $140,499–$180,000 annual base pay.

Company

hirify.global develops products and services for the medical technology sector.

What you will do

• Lead governance, effectiveness, harmonization, and continuous improvement of the global Quality Management System.
• Own the global Management Review program, including planning, reporting, action tracking, and improvement.
• Develop QMS KPIs, dashboards, and executive-level reporting on compliance, risks, and performance.
• Monitor global regulations and standards, lead impact assessments and gap analyses, and implement resulting QMS changes.
• Lead quality systems due diligence, integration planning, and harmonization for acquisitions and strategic initiatives.
• Lead, coach, and develop a team responsible for quality systems governance, reporting, compliance monitoring, and improvement.

Requirements

• 8+ years of experience in quality management systems within a regulated medtech industry.
• 7+ years of people leadership and team development experience.
• Experience with ISO 13485, FDA 21 CFR Part 820, MDSAP, and EU MDR requirements.
• Strong working knowledge of MasterControl, Veeva, TrackWise, or similar eQMS platforms.
• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related field.
• Strong analytical, organizational, communication, and cross-functional collaboration skills.

Nice to have

• Experience with enterprise software implementations, data migration, and data mapping.
• Advanced Excel proficiency for data analysis and reporting.
• ASQ quality certification, CQA or similar certification, or PMP.
• Experience supporting internal and external audits or additional 21 CFR Part 210/211 requirements.

Culture & Benefits

• Standard office environment with computer-based work and virtual collaboration tools.
• Medical coverage, 401(k), parental leave, fertility benefits, and paid vacation, personal, sick, and holiday time.
• Additional compensation and employee benefits may be available.