2 дня назад
Senior Quality Engineer (Life Sciences)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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 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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