Senior Quality Expert - Microbiology and Environmental Monitoring
Senior Quality Expert - Microbiology and Environmental Monitoring
We're supporting a global leader in life sciences in the search for a Senior Quality Expert - Microbiology & Environmental Monitoring to join their high-performing Quality team.
This is a fantastic opportunity for an experienced microbiology professional to play a pivotal role in post-market quality, complaint handling, and continuous improvement within a regulated manufacturing environment.
You will take ownership of complaint investigation and quality issue resolution, acting as a key interface between internal teams and customers. This role sits at the heart of quality excellence-driving root cause analysis, ensuring compliance, and improving product performance.
Key responsibilities:
- Lead Complaint Defect Tracking & Resolution (CDT&R) activities across assigned products
- Conduct complaint triage, trend analysis, and coordinate cross-functional investigations
- Author and review technical investigation reports and customer-facing documentation
- Act as a subject matter expert in microbiological quality, supporting containment, root cause analysis, and CAPA
- Manage field actions and risk assessments, ensuring appropriate escalation and regulatory compliance
- Generate and present quality metrics (complaints, CAPA, non-conformances) to support continuous improvement
- Collaborate closely with Manufacturing, Engineering, and Regulatory teams to ensure timely resolution of issues
Expertise:
- Bachelor's degree (Microbiology preferred), with advanced training (ASQ or similar) highly desirable
- Experience as a Quality Engineer, Quality Specialist or Quality Manager with exposure to microbiology in a life science, food, or similar setting
- Strong microbiology lab experience, including:
- Microorganism identification (bacteria, yeast, mould)
- Gram staining and microscopy
- Environmental monitoring in controlled manufacturing environments
- Proven experience within a regulated industry (life sciences, medtech, pharma, food, dairy or similar)
- Strong data analysis capability, with proficiency in Excel (incl. pivot tables), PowerPoint, Word, and Teams
- Experience working with complaints, CAPA, investigations, and post-market quality systems
- Excellent written and verbal communication skills, with the ability to interface with customers