Quality Assurance Manager

A growing, innovative medical device company developing a platform for interventional gastrointestinal procedures. The system combines a reusable control module with a portfolio of single-use catheters in multiple sizes and configurations.
The role

You'll lead the day-to-day Quality function and act as a trusted, independent Quality partner across Design & Development, NPI, Manufacturing, Regulatory, Commercial Operations and senior leadership. You'll own and continually improve the quality system, approve product and process activities, and drive practical, risk-based resolution of quality issues in a small organisation.
This suits someone who is comfortable making sound decisions when information is incomplete, who works constructively with teams to find a compliant path forward, and who has the confidence to pause an activity when a real quality, compliance or patient-safety concern remains unresolved.
Key responsibilities

Lead the Quality function hands-on, setting priorities and maintaining and improving the QMS (procedures, records, training, document control)
Provide Quality Engineering support across design controls, risk management, verification/validation, design transfer and change control
Support manufacturing quality, including process validation (IQ/OQ/PQ), inspection and test method qualification, and production controls
Own or facilitate nonconformance, CAPA and investigation processes, from root cause through to effectiveness checks
Provide Quality oversight of complaint handling, returned-product evaluation and post-market trending, working with Regulatory on reportability decisions
Establish risk-based supplier controls, including qualification, monitoring and supplier corrective actions
Keep the company inspection-ready, supporting internal, customer and external audits and regulatory inspections
Develop quality metrics and support Management Review
Must-have experience

8+ years in Quality Engineering or Quality Assurance within the medical device industry, with increasing responsibility
Strong working knowledge of 21 CFR Part 820 / QMSR, ISO 13485 and ISO 14971
Hands-on experience with design controls, risk management, V&V, design transfer, process validation and change control
Experience with NCRs, CAPA, root-cause investigation, complaint handling and supplier quality
Experience reviewing and approving technical quality records, with strong technical writing skills
Proven ability to manage a broad Quality workload independently in a small or cross-functional organisation
Confidence engaging senior leaders, engineers, production teams, suppliers, auditors and regulators
Bachelor's degree in Engineering, Life Sciences or a related discipline (or equivalent experience)

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