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2 часа назад

Quality Manager - Environmental Services

116 000 - 174 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
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
Quality Manager - Environmental Services (Medical Devices/Regulatory Compliance): Managing quality and regulatory compliance for medical device and drug combination product processes with an accent on QSR, GMP, ISO standards, complaint investigations, and continuous improvement. Focus on coordinating design controls, risk management, validation activities, and quality issue resolution while leading departmental teams.

Location: Northfield, Illinois, United States; travel up to 25% within the state, out of state, and internationally.

Salary: $116,000–$174,000 annually; bonus and/or incentive eligible.

Company

hirify.global is a worldwide organization providing products and services for healthcare and regulated industries.

What you will do

  • Manage quality and regulatory compliance for assigned products, processes, departments, and distribution regions.
  • Coordinate with divisions, suppliers, manufacturing, and operations to support product quality and customer satisfaction.
  • Manage complaints, investigate quality issues, and develop problem-solving approaches.
  • Identify and execute continuous improvement projects and support product evaluations from quality and regulatory perspectives.
  • Plan and support design, testing, inspection, and process validation activities.
  • Lead departmental operations, staffing, performance management, training, work assignments, and policy implementation.

Requirements

  • Bachelor’s degree in Engineering, Science, or a technical field.
  • At least 4 years of experience with medical device or drug combination product platforms, design controls, risk management, and regulated-industry requirements.
  • Knowledge of QSR, GMP, ISO 13485, ISO 14971, MDSAP, MDR, and 21 CFR 820.
  • Ability to analyze and report data, coordinate concurrent projects, manage competing priorities, and meet critical deadlines.
  • Advanced Microsoft Excel skills, including pivot tables and data analysis.
  • Ability to travel up to 25% for business purposes.

Nice to have

  • At least 2 years of supervisory or managerial experience.
  • Experience in medical device, pharmaceutical, food, cosmetic, or personal products industries.

Culture & Benefits

  • Competitive total rewards package.
  • Continuing education and training opportunities.
  • Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
  • Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for applicable employees.
  • Inclusive workplace focused on diversity, belonging, and career growth.

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