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1 день назад

QA Senior Manager (Medical Devices)

132 037 - 178 638$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Текст:
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TL;DR
QA Senior Manager (Medical Devices): Leading quality oversight and remediation programs for external mechanical device suppliers with an accent on supplier quality systems, regulatory compliance, and global operations. Focus on managing quality professionals, escalating supplier risks, and driving cross-functional improvements across medical device and biopharmaceutical activities.

Location: US - Massachusetts - Cambridge; travel up to 25%, including domestic and international travel.

Salary: $132,037.30–$178,638.70 annually.

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

  • Program-manage remediation activities for assigned critical external mechanical device suppliers.
  • Lead quality professionals overseeing external device suppliers.
  • Monitor supplier quality systems, performance, KPIs, and risk escalations.
  • Define and enforce quality requirements across global operations.
  • Collaborate with External Supply, Process Development, and Combination Product Quality teams.
  • Drive cross-functional initiatives, continuous improvement, and operational excellence.

Requirements

  • Doctorate degree and 2 years of experience, or a master's degree and 4 years, or a bachelor's degree and 6 years, or an associate's degree and 10 years, or a high school diploma/GED and 12 years of experience.
  • 10+ years of experience in medical device, pharmaceutical, or biotechnology sectors preferred.
  • Knowledge of quality systems, including batch release, complaints, and risk management.
  • Knowledge of global supplier management and device regulations.
  • Strong leadership, communication, and problem-solving skills.
  • Experience managing global teams, including during organizational change.

Nice to have

  • Degree in biology, engineering, pharmaceutics, biotechnology, or physics.

Culture & Benefits

  • Collaborative, innovative, and science-based work environment.
  • Health, dental, vision, life, disability, and flexible spending benefits.
  • Retirement and savings plan with company contributions.
  • Discretionary annual bonus program and stock-based long-term incentives.
  • Paid time off and career development opportunities.
  • Flexible work models where applicable.

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