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 biotech products delivering meaningful health impact. This is a hands-on, high-impact role combining microbiology expertise with quality engineering to drive investigations, CAPA planning, and regulatory compliant resolutions.

You will own complaint investigations end-to-end, develop quality metrics, coordinate with cross-functional teams, and interface with customers as

Qualifications

• Bachelor’s degree in microbiology or related field.
• ASQ certification or equivalent professional society training.
• Master’s degree preferred for advanced roles.

Responsibilities

• Lead complaint defect tracking and resolution activities for assigned products.
• Author and review investigation summaries and customer-facing reports.
• Provide SME on containment actions, root cause analysis, and CAPA planning.
• Manage field actions and coordinate regulatory compliant risk assessments.
• Generate quality metrics for non-conformances, CAPAs, complaints and field actions.

Skills

Complaint investigations

Root cause analysis

CAPA leadership

Quality metrics development

Cross-functional collaboration

Education

Bachelor's degree in Microbiology

ASQ certification

Master’s degree (preferred)

Tools

Excel (pivot tables)

PowerPoint

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

• 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.