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7 дней назад

Dir Manufacturing 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 Manufacturing Quality (Medical Devices/Quality Compliance): Leading quality teams and developing product specifications, supplier quality programs, and regulatory compliance strategies for medical device and combination product platforms with an accent on FDA, QSR, GMP, and ISO requirements. Focus on directing multi-level management, coordinating suppliers and manufacturing partners, and ensuring compliance with 21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.

Location: Arlington Heights, Illinois, United States. The position requires travel of up to 30% within the state, nationally, and internationally.

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

Company

hirify.global develops and supplies medical products and operates a growing worldwide organization.

What you will do

  • Lead Quality teams and develop long-term strategies, functional plans, budgets, and operational priorities.
  • Direct product specifications, testing requirements, inspection methods, and qualification processes for branded products and suppliers.
  • Partner with Supplier Audit, manufacturing partners, suppliers, product managers, and divisional leadership on quality programs and supplier relationships.
  • Oversee QSR compliance and readiness for FDA, ISO, and internal audits.
  • Prepare customer presentations and act as a liaison among senior leadership, suppliers, manufacturing, and operations.
  • Hire, develop, evaluate, and manage staff through multiple managers while ensuring consistent policy execution.

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 of managerial experience preferred.
  • 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

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

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