Principal Laboratory Analyst (Medical Devices)

LIKELY QUESTIONS

- How have you verified analytical methods, including accuracy, precision, linearity, robustness and suitability for their intended use?
- Describe your experience with qualification or verification of HPLC/GC columns, Class A glassware and other laboratory consumables.
- What medical device, health product testing or related laboratory activities have you performed, and how do they differ from pharmaceutical testing?
- How would you implement and monitor biosafety and biosecurity controls in a medical-device testing laboratory?
- Describe how you ensure analytical samples are correctly received, labelled, sorted, stored, tracked and disposed of.
- Tell us about your experience implementing a quality management system, particularly document control, deviations, change control and risk management.
- What role have you played in internal audits, laboratory investigations and CAPA management?
- How would you support post-market surveillance of health products or medical devices, including sample testing, data integrity and reporting?

BEHAVIOURAL QUESTIONS

- Tell us about a time you identified a laboratory non-conformance before it affected a reported result.
- Model approach: Situation: Briefly describe the non-conformance, such as an out-of-specification control, incomplete sample chain of custody or equipment calibration concern. Task: Explain your responsibility for protecting result validity and compliance. Action: Describe how you stopped or contained the issue, documented it, investigated root cause, involved relevant personnel and initiated CAPA. Result: State the outcome, such as prevented release of unreliable results, improved a procedure and reduced recurrence.

- Describe a time you managed competing priorities in a high-volume laboratory environment.
- Model approach: Situation: Describe a period with urgent samples, routine testing, audit preparation or equipment constraints. Task: Explain the deadlines, quality requirements and stakeholders involved. Action: Show how you risk-prioritised work, allocated resources, communicated turnaround expectations and maintained documentation review. Result: Quantify timely completion, reduced backlog or successful delivery without compromising quality.

- Give an example of when you improved a laboratory safety, biosafety or waste-management process.
- Model approach: Situation: Identify a safety gap, such as inconsistent MSDS access, chemical segregation, PPE compliance or waste labelling. Task: Explain your role in addressing the risk. Action: Describe your risk assessment, consultation with users, revised procedure, training and monitoring measures. Result: State the measurable safety or compliance improvement and how you sustained it.

- Tell us about a time you handled disagreement during an audit finding, investigation or CAPA discussion.
- Model approach: Situation: Describe the audit finding or investigation where colleagues disagreed on the root cause or corrective action. Task: Explain your need to maintain objectivity, compliance and collaboration. Action: Describe how you used evidence, records, risk assessment and applicable procedures to guide discussion and agree actions. Result: Highlight closure of the finding, stronger controls and improved working relationships.

SMART QUESTIONS TO ASK

- What types of medical devices, health products or HPTs are most frequently handled by the laboratory, and what are the main testing or surveillance priorities for this role?
- What quality management standard or regulatory framework governs the laboratory's medical-device-related activities, and where are the key improvement priorities?
- How is post-market surveillance coordinated between the laboratory, regulatory teams, inspectors and external stakeholders?
- What are the most common audit findings, CAPA challenges or sample-management risks currently facing the laboratory?
- At the end of the two-year contract, what outcomes would demonstrate that the Principal Laboratory Analyst has been successful?

RED FLAGS TO WATCH FOR

- Unclear answers about applicable quality standards, documented procedures, accreditation status or how audit findings and CAPAs are tracked to closure.
- Statements suggesting urgent turnaround is routinely prioritised over sample chain of custody, method verification, equipment qualification or independent result review.
- Vague ownership of biosafety, chemical waste, incident reporting and post-market surveillance responsibilities, especially where staff appear to rely on informal practices rather than documented controls.