Senior Microbiology Quality Engineer

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

A global leader in life sciences and biotechnology is looking for a Senior Microbiology Quality Engineer to lead post-market quality activities for a portfolio of products that genuinely make a difference to human health.

This is a hands‑on, high‑impact role where your microbiology expertise and quality engineering skills come together. You'll own complaint investigations end‑to‑end, drive root cause analysis, and interface directly with customers - all whilst helping to continuously improve the products and processes patients and clinicians rely on.

If you enjoy technical problem‑solving, cross‑functional collaboration and being the go‑to expert for quality resolution, this could be your next move.

What You'll Do

The Opportunity

A global leader in life sciences and biotechnology is looking for a Senior Microbiology Quality Engineer to lead post-market quality activities for a portfolio of products that genuinely make a difference to human health.

This is a hands‑on, high‑impact role where your microbiology expertise and quality engineering skills come together. You'll own complaint investigations end‑to‑end, drive root cause analysis, and interface directly with customers - all whilst helping to continuously improve the products and processes patients and clinicians rely on.

If you enjoy technical problem‑solving, cross‑functional collaboration and being the go‑to expert for quality resolution, this could be your next move.

What You'll Do

• Lead Complaint Defect Tracking & Resolution (CDT&R) activities for assigned products, including complaint triage, trend analysis and coordination of investigations to ensure timely, compliant resolution of post‑market quality issues.
• Author and review high‑quality investigation summaries and customer‑facing technical reports, interfacing directly with customers as needed.
• Provide subject matter expertise on containment actions, root cause analysis, investigation execution and CAPA planning for internal non‑conformances.
• Manage field actions and facilitate formal risk assessments, ensuring appropriate escalation, documentation and regulatory compliance.
• Generate and present quality metrics related to non‑conformances, CAPAs, complaints and field actions, contributing to continuous improvement initiatives.

What You'll Bring

• Bachelor's degree, ideally with a microbiology background and/or professional training through ASQ or a relevant professional society (or a master's degree).
• Minimum of 5 years' relevant experience in a regulated environment such as GMP medical devices or pharmaceuticals, with at least 3 years coordinating post‑market surveillance and quality activities (complaint triage, investigations, CAPA).
• Microbiology laboratory competence - including microscopic differentiation of microorganisms (bacteria, yeast, mould), Gram staining and environmental monitoring in controlled manufacturing environments.
• Experience with cGMP and/or ISO 13485 quality systems, including documentation practices, audits, change control and validation.
• Strong data analysis skills, with proficiency in Excel (formulas, pivot tables), PowerPoint, Word and Teams.