Senior Microbiology Quality Engineer
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.
FAQs
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