Quality Control Manager – Assays

About the role

The Quality Control Manager – Assays will design and own the measurement and control system for assay‑critical raw materials, intermediates, assembled strips and finished diagnostic products. The role translates assay performance and product risk into practical specifications, QC methods, sampling plans and statistical controls.

Key responsibilities

• Define critical quality attributes, control points, specifications, sampling plans and acceptance criteria for assay‑critical materials and finished products.
• Own or approve fit‑for‑purpose QC methods for antibodies, antigens, conjugates, membranes, pads, buffers, printed components and kits, and qualify measurement systems.
• Assess vendor laboratory capability, lead method transfer, and establish quality‑agreement responsibilities for testing and data access.
• Ensure complete, traceable batch‑release packages, lead OOS/OOT investigations and drive CAPA effectiveness.
• Build dashboards and statistical controls to detect drift, monitor precision, yield, deviations and vendor trends.
• Develop risk‑based stability programmes and connect field‑quality signals to raw‑material and process data.
• Maintain inspection‑ready QC records and support ISO 13485/FDA QMSR audits.

Required profile

• 8‑12 years of quality control, manufacturing quality or supplier quality experience in medical products, diagnostics or high‑volume electronics.
• Hands‑on experience with specifications, sampling/inspection plans, acceptance tests, measurement‑system qualification and product release.
• Strong statistical judgement, trending, SPC, process capability and measurement‑system analysis.
• Bachelor’s or Master’s degree in Engineering, Science or related technical discipline (or equivalent experience).
• Demonstrated ability to audit suppliers, drive corrective actions and influence cross‑functional teams.

Required skills

• Audit readiness
• Measurement systems qualification
• Sampling plans
• ISO 13485
• Vendor QC capability
• FDA QMSR
• Acceptance criteria definition
• QC methods development
• Statistical controls and SPC
• CAPA management