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4 дня назад

Dir, QA (Product Quality)

154 000 - 231 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Dir, QA (Product Quality) (Medical Devices/Quality Systems): Leading product quality and compliance strategy for medical device and combination product platforms with an accent on design controls, risk management, supplier quality, and FDA/ISO requirements. Focus on directing quality teams, developing product specifications and QA programs, and ensuring compliance with QSR, GMP, ISO 13485, ISO 14971, MDSAP, and MDR.

Location: Northfield, Illinois, United States; travel up to 30% within the state, nationally, and internationally.

Salary: $154,000–$231,000 annual, plus bonus and/or incentive eligibility.

Company

hirify.global is a healthcare products organization offering medical and regulated product solutions through a growing worldwide operation.

What you will do

  • Lead quality teams and establish long-term strategic, tactical, and operational plans for assigned departments.
  • Direct product specifications, testing requirements, inspection methods, qualification processes, and supplier quality activities.
  • Develop and implement quality strategies based on quarterly management reviews.
  • Collaborate with suppliers, manufacturing partners, product managers, and senior leaders to deliver compliant products and meet customer requirements.
  • Oversee QSR compliance and audit readiness against FDA, ISO, and internal standards.
  • Manage budgets, staffing, performance reviews, training, work assignments, and policy implementation.

Requirements

  • Bachelor’s degree in Engineering, Science, or a technical field.
  • At least 7 years of experience with medical device or drug combination product platforms, design controls, risk management, and regulated quality systems.
  • At least 4 years of management experience; 6 years preferred.
  • Technical knowledge of 21 CFR 820, ISO 13485, ISO 14971, MDSAP, MDR, QSR, and GMP requirements.
  • Ability to analyze and report data, coordinate concurrent projects, manage competing priorities, and meet critical deadlines.
  • Advanced Microsoft Excel skills and willingness to travel up to 30% for business purposes.

Nice to have

  • At least 8 years of related experience in medical device, pharmaceutical, food, cosmetic, or personal products industries.

Culture & Benefits

  • Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
  • Access to an Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.
  • Continuing education and training opportunities.
  • Inclusive workplace focused on belonging, career growth, and equal employment opportunity.

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