Senior Microbiology Quality Engineer

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.