Ian Phillip McElhoney

Managing a group of globally based, experienced professionals across six manufacturing sites. I lead complex and strategic initiatives in collaboration with other Convatec Senior leaders that develop and enhance Convatec’s Global Supplier Quality program.

Responsible for the establishment, management, and continued development of Global Supplier Quality including, Contract Manufacturing Quality Assurance (CMO QA) and Supplier Quality (SQ) functions.

This role encompasses overseeing the Quality Engineering, Quality Control, Supplier Quality and Complaint Investigation teams responsible for the compliance, final disposition and release of all contract-manufactured and internally manufactured goods globally, with a specific focus on the four organization value streams: Advanced Wound Care (AWC), Ostomy (OST), Continence Care (CC) and infusion care (IC)

Key tasks:

• CAPA NC SCAR Management
• Change Control and Product Life Cycle Management
• Customer Complaint Management
• Quality Agreement negotiation and approval.
• Leading External audit preparation and execution globally.
• Lead the development and deployment of Global Supplier Quality and External Manufacturing strategic initiatives that align with business and compliance needs across the enterprise.
• Partner with senior leaders in other departments to align on strategies and policies across their respective areas, ensuring alignment with Global Supplier Quality, which include but not limited to BU Quality leads, Supply Chain, NPD, Operations, Packaging and Regulatory.
• Work with Procurement in their strategic operations to identify and certify alternative suppliers, mitigating risks of supply disruption and optimizing location/cost benefits for Convatec.
• Guide supplier selection, evaluation, and approval processes as needed, ensuring alignment with technical standards and regulatory requirements.
• Lead the establishment and management of strategic supplier relationships to align with Convatec’s quality, performance, and business objectives.
• Identify and mitigate risks related to supplier quality, compliance, and business continuity.
• Negotiate and enforce supplier quality agreements, ensuring compliance with legal, regulatory and contractual requirements.
• Define and track KPIs through performance management reviews to drive supplier performance and ensure the timely resolution of quality and service issues.
• Ensure Supplier Performance metrics are central in Procurement Supplier performance processes and reviews.
• Communicate strategic initiatives clearly to the wider quality organization and senior leaders, demonstrating confidence and expertise.
• Optimised supply chain processes with vendor negotiations.
• Ensured regulatory compliance through meticulous auditing procedures.
• Facilitated cross-functional collaboration leading to improved operational efficiency.
• Driven change management initiatives resulting in organisational agility.

Global Head of Supplier Quality managing a team of global quality engineers. Global complaint head for third party manufacture. Management of batch release and change control. Quality agreement creation and the global face for supplier Quality. Coaching Quality excellence in all we do to deliver results.

Key Tasks:

• Quality Management of third-party manufacturers.
• Management of vendors and vendor process including onboard, risk based and phase appropriate qualification oversight, and ongoing monitoring.
• Provides tactics to address compliance gaps or determines enhancements to cross-functional vendor quality management process.
• Monitor health of vendor quality management system as well as vendor performance through audits, inspections, SCARs, and other inputs. Ensures escalation and increased governance of low performing vendors and tracks the risks and mitigation plans.
• Work with global quality and functional areas to ensure vendor qualification program is scalable and flexible including integration of new modalities into the quality systems.
• Management of the complaints handling process. Customer complaint investigation and escalation to manufacture. CPM reduction and improvement.
• Collaboration with Site Leadership team and all department heads to ensure regulatory compliance, cGMP and quality assurance are a shared responsibility.
• Identification, remediation, and escalation of all compliance issues with the potential to cause critical or major audit observations.
• Lead innovation and improvements of processes in relation to the Convatec Quality Systems.
• Drive audit preparation for FDA/MDSAP and global regulatory audits including, China Korea, Taiwan.
• Management of SCARs CAPAs and NC actions through to closure with robust actions.
• Stop Shipment and HHE management.
• Head Change Control through to Implementation
• Quality Agreement, creation, negotiation, and execution
• TP/TF technical specification review including COC and COA
• Batch release management.
• Drive SOP creation and approval.
• Ensure all activities comply with the requirements of the manufacturing and distribution licenses, national and international guidelines appropriate to the destination market, marketing authoritarians and Clinical Trial Authorizations.
• Activities related to new product launch and life cycle management of legacy products, including test method validation, product risk analysis, design control, change control, material changes.
• Creation, development, and management of post market surveillance group supporting complaint handling, new product development, product risk, and regulatory activities within main business franchises.

UK Quality Manager for Sunrise Medical including RGK Wheelchairs and The Helping Hand Company.

Key Tasks:

• ISO13485 and ISO9001 audit and QMS specialist, managing Quality across 4 sites across the United Kingdom managing a team of 10 quality professionals.
• UK Quality head for customers at NHS England Scotland and Wales.
• Reporting/Improving CoGQ Cost of good quality & CoPQ Cost of bad quality
• Project manage the roll out of iAuditor software in the production facility.
• Oversee the review, update, and implementation of procedures to ensure compliance to regulations and standards.
• Develop quality metrics/indicators to track performance and compliance and analyse data to develop and implement improvements to streamline and improve quality processes and procedures.
• Management of the Quality Engineers who review and approve corrections, corrective actions, and preventative actions. Oversee 8D for issuance, review, and closure of action plans. Responsible for ensuring NCR and 8D investigations are robust and that corrections and/or corrective actions taken eliminate the non-conformance.
• Being the company representative for external surveillance and recertification audits.
• Chairing management reviews.

National Quality and Compliance Manager reporting direct into the company director,

Key Tasks:

• Ensuring quality and compliance levels within the company are brought in line with successful company growth.
• Being the face of Field Quality and Compliance to customers across the United Kingdom.
• Creation and implementation of a new customer facing NCR (Non-Conformance) process and procedure.
• Risk Assessment creation. Customer Satisfaction vs Profitability
• National Management of Quality and Compliance relating to Installations.
• Creation and implementation of KPI metrics.
• Quality and Compliance updates to the company directors.
• Interaction with Business intelligence and Development.
• Interaction with customers across the UK.
• Process improvement review - reviewing current install process and feedback
• Recommendation for improvement to company directors.
• Implementation of company document review process.
• Implementation of SPL (Single Point Lesson) to the Engineering team.
• Bringing the company inline with ISO9001 and putting processes in place to reflect this.
• Bringing installs in line with TL900.
• Assisted in the development of company-wide corrective action plans following internal or external audit findings.

Lead Quality Assurance Engineer managing a team of 6 Quality Engineers within the production department of a biotechnology company working to improve the quality system.

Key Tasks:

• Ensuring that the site adheres to ISO 13485: 2016, FDA 820.11 and ISO 9001: 2015
• Management of 6 Quality Engineers.
• IPD team appraisal creation and monitoring.
• Audit preparation (FDA BSI) (MDSAP)
• GMP monitoring and feedback.
• Management of the CAPA system.
• Management of the NCR system.
• Project improvement - Creation and rolling out and training of a new NCR procedure.
• CAPA system improvement project.
• NCR and CAPA investigation.
• Creation of monthly Quality metric KPI.
• Leadership and improvement meetings.
• HR meetings.
• Recruitment/Interviews/HR investigations
• Communication and updates to company directors

• FDA/SGS/BSI Compliance and participating in audits.
• SOP (standard operating procedure) creation and management.
• Undertake internal audits in accordance with the internal audit schedule.
• Being part of the CAPA review board.
• Creation and investigation of CAPA system
• Create and maintain a CAPA tracker.
• Non-Conformance investigation
• Complaint handling (customer based)
• Change control
• Tribology testing of orthopaedic prostheses retrieved after a surgical revision procedure.
• Failure analysis of returned hip replacements.
• Technical support for onsite manufacturing.
• Organisation of calibration and maintenance of laboratory equipment.
• Creation of research reports (clinical studies)
• Help maintain and run the site quality system.
• Create and amend standard operating procedures.
• Obeya room creation and management (LEAN)
• Ensuring accurate records are maintained

• To provide advice and support in the use of quality systems. To assist in monitoring the site quality system on a day-to-day basis, ensuring that all licensing and accreditation activities are undertaken as they should be. To support the delivery of essential training to staff and monitor the quality system performance across the Trust.
• A key activity was the facilitation and management of the Incident Management system, in collaboration with the Clinical Governance team, and the engagement of internal and external business users.
• Handling and investigating Customer complaints relating to surgical procedures.
• Meeting BSI standards and passing quarterly audits
• Liaising with Surgeons and theatre personal and resolving issues.
• Creating Instrumentation checklists.
• Investigating circumstances and providing findings to management.
• Creating spreadsheets and finance reports.
• KPI data analysis.
• Contacting and meeting customers (Surgeons and senior healthcare staff).
• Raising and closing corrective actions.
• Ensuring accurate records are maintained.
• Undertaking internal audits.