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2 дня назад

Senior Quality Engineer (Life Sciences)

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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Описание вакансии

Текст:
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TL;DR
Senior Quality Engineer (Life Sciences): Supporting manufacturing quality processes in a regulated life sciences environment with an accent on quality data analysis, root cause investigations, CAPA, audits, and continuous improvement. Focus on reducing quality risk, ensuring regulatory compliance, and resolving cross-functional manufacturing quality issues.

Location: Pensacola, Florida, United States; on-site role

Company

hirify.global operates Cytiva, a life sciences company providing solutions for biological research, vaccines, medicines, and cell and gene therapies.

What you will do

  • Analyze quality and production data, identify trends and KPIs, and implement data-driven improvements using lean principles.
  • Conduct root cause investigations using CAPA, 8D, Fishbone, and 5 Whys methodologies.
  • Monitor shop floor processes for compliance with specifications, control plans, and standard work instructions.
  • Participate in internal, layered process, external, and customer audits while maintaining quality documentation.
  • Act as the quality liaison between Manufacturing, Engineering, Supply Chain, customers, and site leadership.
  • Support deviations, investigations, CAPA, change management, and process improvement initiatives across the site.

Requirements

  • 5+ years of experience in Quality Engineering or Quality Systems within a regulated manufacturing environment.
  • Bachelor’s degree in engineering, science, or a related technical discipline preferred.
  • Experience with contamination control, sterility assurance, SPC, and lean methodologies.
  • Knowledge of applicable regulatory requirements in regulated life sciences or material science environments.
  • Ability to collaborate cross-functionally in a fast-paced production environment.
  • Ability to lift, move, or carry equipment weighing up to 50 lb.

Nice to have

  • Experience in life sciences, biotechnology, pharmaceutical, or medical device manufacturing.
  • Familiarity with FDA, ISO, and GMP regulatory expectations.
  • Lean, Six Sigma, Green Belt, or CQE certification.

Culture & Benefits

  • Continuous improvement culture based on the hirify.global Business System.
  • Medical, dental, and vision insurance for eligible employees.
  • Paid time off and 401(k) benefits for eligible employees.
  • Eligibility for bonus or incentive pay.

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