Katrina Mullally

Senior Quality professional with 13+ years' experience across medical-device manufacturing and regulated healthcare, with a strong track record in Quality systems, auditing, CAPA, root-cause analysis, KPI reporting, process improvement and cross-functional project delivery. Proven ability to design and improve Quality processes, manage audit activity from preparation through corrective-action close-out, analyse performance trends and translate findings into practical improvements that strengthen compliance, service consistency and operational performance. Led ISO 13485 implementation within 4 months with zero non-conformances and later delivered HPRA inspection readiness within 11 months with zero non-conformances.

Experienced in influencing stakeholders across Quality, Engineering, Production, Operations, healthcare, suppliers and external partners, working independently while maintaining strong governance, accountability and follow-through.

Clerical Officer – Remote - HSE / Vision Consulting - Remote

(2025-01)

Following a change in personal circumstances, deliberately moved into a remote healthcare assignment while continuing to apply Quality-control, data-review and compliance skills within a national HSE programme.

• Support a national initiative focused on reducing healthcare waiting lists.
• Consistently meet or exceed productivity and call-quality targets.
• Review completed work from other agents for accuracy, completeness and process adherence before information is provided to HSE Area Managers.
• Identify errors, omissions, inconsistencies and process deviations and ensure appropriate correction.
• Maintain high standards of data accuracy, confidentiality and GDPR compliance.
• Analyse case information and escalate issues where required.
• Work independently in a high-volume remote environment while maintaining strong Quality and service standards.

Founder & Operations Manager - Eden Rejuvenation

(2023-01)

• Built and manage all aspects of a customer-focused business.
• Develop and improve operational processes to increase efficiency and service consistency.
• Manage suppliers, customer experience, scheduling, financial administration and budgets.
• Monitor customer feedback and use findings to identify service improvements.
• Use Microsoft 365, ChatGPT, Copilot and digital tools to streamline administration and communication.

General & Quality Manager - FIVF Ireland / Institut Marquès

(2017-01 - 2023-12)

Senior management role spanning Quality, compliance, risk, operations, reporting, suppliers and stakeholder management.

• Independently researched HPRA requirements, completed a regulatory gap assessment and developed the systems required for inspection readiness.
• Achieved HPRA inspection readiness within 11 months with zero non-conformances.
• Managed CAPA, Change Control, non-conformances, risk assessments and validation.
• Planned and supported internal and external audits and regulatory inspections.
• Reviewed audit evidence, documented findings and monitored corrective actions through close-out.
• Verified completion and effectiveness of actions arising from Quality and compliance reviews.
• Conducted root-cause investigations and implemented corrective actions.
• Managed Quality and document systems using Pulse and structured Excel-based controls.
• Developed and maintained Quality documentation, audit records, SOPs, procedures and compliance trackers.
• Prepared and led quarterly Management Reviews.
• Analysed Quality KPIs, CAPA trends, Change Controls, audit findings, complaints, risks and recurring issues.
• Used performance data to identify priorities, emerging risks and opportunities for improvement.
• Presented findings, trends and recommendations to senior management and other stakeholders.
• Developed and monitored corrective-action and improvement plans.
• Established feedback loops to ensure actions were followed through and improvements sustained.
• Used audit findings, operational data and stakeholder feedback to strengthen service delivery and process consistency.
• Facilitated cross-functional reviews with senior leadership, clinicians, HSE partners, laboratories, suppliers and external service providers.
• Aligned stakeholders on risks, priorities, corrective actions and improvement requirements.
• Coordinated complex cross-functional workstreams and competing priorities.
• Managed supplier and service-provider relationships.
• Maintained service continuity throughout COVID-19 while adapting operational processes to changing requirements.
• Led Occupational Health & Safety activity during CHKS accreditation.

Senior Quality Engineer - MGS Manufacturing Group

(2010-01 - 2017-12)

Senior Quality role within a regulated medical-device manufacturing organisation, with several multinational customers where I was the quality point of contact.

• Led implementation of ISO 13485, achieving certification in 4 months with zero non-conformances.
• Developed and standardised Quality processes, supporting documentation and audit controls.
• Planned and supported internal, customer and certification audits from preparation through findings and corrective-action close-out.
• Managed audit findings and verified effectiveness of completed actions.
• Managed CAPA, MRB, Change Control, non-conformances and risk assessments.
• Conducted root-cause investigations and implemented corrective and preventive actions.
• Maintained controlled Quality documentation and records.
• Identified weaknesses in the existing Change Control process and redesigned it to improve governance, accountability, traceability and workflow efficiency.
• Used Quality data, CAPA trends, audit findings and investigations to identify recurring issues and prioritise improvement actions.
• Implemented corrective and preventive actions designed to prevent recurrence and strengthen process performance.
• Supported continuous-improvement initiatives across Production, Engineering and Quality.
• Standardised Quality activities and supporting documentation to improve consistency and audit readiness.
• Supported multinational customers including BD, Coloplast and KCI.
• Coordinated New Product Introduction and technology-transfer activity.
• Managed supplier and customer Quality issues.
• Facilitated cross-functional reviews involving Engineering, Production, Operations, suppliers and customers.
• Managed validation activity including IQ, OQ, PQ, process, equipment and cleanroom validation.
• Prepared validation plans, protocols and reports.
• Coordinated project actions, risks, documentation and Quality deliverables through to completion.

Bachelor of Science - Quality

Certificate - Supervisory Management

Certification - Lean Six Sigma

Certification - ISO 13485 Internal Auditor

Certification - ISO 9001 Internal Auditor

Certification - GDPR