Impactful Microbiology Quality Engineer - Post-Market

EPM Scientific; Hauppauge (NY); On-site; USD 120,000 - 160,000; Full time

Job summary

EPM Scientific is seeking a Senior Microbiology Quality Engineer to lead post-market quality activities for a portfolio of products that impact human health. This hands-on role focuses on complaint investigations end-to-end, root cause analysis, and direct customer interface to drive continuous quality improvements.

You will own investigations, author high-quality reports, and provide SME input on containment actions and CAPA planning, while supporting field actions and risk assessments.

Qualifications

• Bachelor's degree with microbiology background and/or master's degree.
• Minimum 5 years' experience in GMP medical devices or pharmaceuticals.
• 3+ years coordinating post-market surveillance and quality activities.
• Microbiology lab competence including environmental monitoring.
• Experience with cGMP and ISO 13485 quality systems.

Responsibilities

• Lead complaint defect tracking & resolution activities end-to-end.
• Author and review investigation summaries and customer-facing reports.
• Provide subject matter expertise on containment actions and CAPA planning.
• Manage field actions with risk assessments and regulatory documentation.
• Generate and present quality metrics related to non-conformances and CAPAs.

Skills

Complaint investigations

Root cause analysis

CAPA planning

Cross-functional collaboration

Data analysis

Education

Bachelor's degree in microbiology

Master's degree (optional)

Tools

Excel

PowerPoint

Word

Teams

Job description

EPM Scientific is seeking a Senior Microbiology Quality Engineer to lead post-market quality activities for a portfolio of products that impact human health. This hands-on role focuses on complaint investigations end-to-end, root cause analysis, and direct customer interface to drive continuous quality improvements.

You will own investigations, author high-quality reports, and provide SME input on containment actions and CAPA planning, while supporting field actions and risk assessments.