Назад
Company hidden
обновлено 5 дней назад

Principal Quality Engineer (Contamination Control Strategy)

116 000 - 174 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Principal Quality Engineer (Contamination Control Strategy) (Pharmaceutical Manufacturing): Leading quality projects and advancing Medline’s global contamination control strategy across pharmaceutical manufacturing operations with an accent on quality systems, risk management, environmental monitoring, and regulatory compliance. Focus on investigating contamination events, implementing CAPA and process improvements, and developing controls for cleanrooms, utilities, gowning, and particulate management.

Location: Northfield, Illinois, United States; travel up to 30% domestically and internationally

Salary: $116,000–$174,000 annual, plus bonus and/or incentive eligibility

Company

hirify.global is a worldwide healthcare organization developing and manufacturing medical and pharmaceutical products.

What you will do

  • Lead quality projects and collaborate with cross-functional internal and external teams.
  • Improve the Quality Management System through compliance, efficiency, process alignment, and cost-of-quality initiatives.
  • Lead root cause investigations, corrective and preventive actions, risk assessments, and remediation activities.
  • Contribute to the global Contamination Control Strategy across the pharmaceutical network.
  • Develop best practices for environmental monitoring, particulate control, gowning, cleaning, cleanroom operations, and critical utility systems.
  • Provide technical leadership and training, and serve as a subject matter expert during audits, inspections, and quality events.

Requirements

  • Bachelor’s degree in mechanical engineering, biomedical engineering, electrical engineering, software engineering, or a related science.
  • At least 7 years of experience in pharmaceutical manufacturing; 10 or more years in pharmaceutical or medical device engineering and/or quality assurance is preferred.
  • Experience leading projects, managing competing priorities, improving QMS processes, and communicating with executive-level stakeholders.
  • Knowledge of risk assessments, FMEA, root cause analysis, investigations, CAPA, compliance documentation, and audit expectations.
  • Ability to travel up to 30% of the time for domestic and international business purposes.
  • Preferred expertise includes microbiology, sterility assurance, environmental monitoring, water and utility systems, laboratory controls, Lean principles, and inspection-ready documentation.

Culture & Benefits

  • Full-time employment within a growing worldwide organization.
  • Health insurance, life and disability insurance, 401(k) contributions, and paid time off for eligible employees.
  • Continuing education and training opportunities.
  • Inclusive workplace focused on belonging, diversity, and career growth.

Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →