Senior Microbiology Quality Engineer - Post-Market CAPA

Radiometer; Hauppauge (NY); Presencial; USD 112.000 - 125.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus/incentive pay

Medical/dental/vision insurance

401(k)

Descripción de la vacante

Cytiva in Hauppauge, NY is seeking a Sr Microbiology Quality Engineer to lead post‑market quality activities, including CDT/ER investigations, containment, CAPA planning, and field actions. The role focuses on customer-facing reports, regulatory compliance, and cross‑functional teamwork to drive improvements.

Applicants should have a microbiology background, 5+ years in GMP environments, and proficiency with Excel, statistics (Minitab), and ISO13485/cGMP systems. On‑site role with benefits.

Formación

• Bachelor’s degree, microbiology preferred; ASQ or related certs encouraged.
• Minimum 5 years in a regulated GMP environment (medical devices or pharma).
• At least 3 years coordinating post-market surveillance, including complaints, investigations and CAPA management.

Responsabilidades

• Lead CDT/ER activities: triage, trend analysis and investigations for post‑market quality issues.
• Author/review investigation summaries and customer-facing reports; interface with customers as needed.
• Provide SME on containment, root cause analysis, investigation execution and CAPA planning for internal nonconformances.
• Manage field actions and conduct formal risk assessments; ensure escalation and regulatory compliance.
• Generate/interpret quality metrics for nonconformances, CAPAs, complaints and field actions; drive continuous improvement.

Conocimientos

Microbiology

Quality engineering

GMP

ISO 13485

Statistical analysis

MicrosoftExcel

PowerPoint

Educación

Bachelor's degree in microbiology

ASQ certification / professional society training

Herramientas

Minitab

Quality Management System (QMS)

MS Office

Descripción del empleo

Cytiva in Hauppauge, NY is seeking a Sr Microbiology Quality Engineer to lead post‑market quality activities, including CDT/ER investigations, containment, CAPA planning, and field actions. The role focuses on customer-facing reports, regulatory compliance, and cross‑functional teamwork to drive improvements.

Applicants should have a microbiology background, 5+ years in GMP environments, and proficiency with Excel, statistics (Minitab), and ISO13485/cGMP systems. On‑site role with benefits.