How can I support your organisation?

Temporary Quality Management when continuity, change or growth requires it.

As an Interim Quality Manager, I support organisations when temporary leadership or additional Quality expertise is needed. This may include temporary replacement, organisational growth, professionalising the quality management system or preparing for certification and audits.

My approach is practical and focused on what the organisation needs at that moment. I bring structure, set priorities and work closely with Quality, Operations and other stakeholders to make improvements work in practice.

Areas I can support:

• Temporary leadership of Quality and QC teams
• Setting up and improving the QMS
• Supporting audits and certification
• CAPA, deviations and structural quality improvement
• Strengthening responsibilities and Quality processes
• Knowledge transfer and coaching

Experience

As an Interim Quality Manager, I have supported organisations in manufacturing and Medical Device environments in achieving BRCGS Packaging and ISO 13485 certification, maintaining and improving ISO 9001 quality management systems, leading Quality/QC teams and building and professionalising quality systems. My aim is not to leave behind a system that remains dependent on a consultant, but an organisation that can continue independently after my assignment has ended.

Control over supplier quality, from qualification and audits to improvement and escalation.

As a Supplier Quality Engineer / Consultant, I support organisations in assessing, qualifying and improving suppliers. I look beyond documentation and procedures, focusing on how quality is controlled in practice and on the risks to products and manufacturing processes.

Areas I can support:

• Supplier qualification and assessment
• Desk audits and on-site supplier audits
• Follow-up of supplier deviations and 8D/CAPA
• Analysis and improvement of supplier performance
• Improvement plans and supplier development
• Escalation of recurring quality issues

Experience

My experience includes supplier assessment and qualification, desk audits, and preparing and conducting on-site supplier audits. In cases of recurring supplier quality issues, I have audited suppliers, developed improvement plans and monitored their implementation. When the required improvements were not achieved, I escalated the quality risks, ultimately resulting in a transition to an alternative supplier.

Practical Quality support within Medical Devices, from QMS and manufacturing to CAPA, audits and validation.

As a Quality Professional, I provide temporary support to Medical Device organisations for replacement, additional capacity and improvement or change initiatives, in roles such as QA Engineer, QA Officer, Quality Systems/QMS Professional and Quality Consultant. My experience covers Quality within Medical Devices across different risk classes, from setting up and improving ISO 13485 quality management systems to operational Quality in manufacturing environments.

Areas I can support:

• Setting up and improving ISO 13485 QMS
• Deviations, NCs and CAPA
• Root cause analysis and structural improvements
• Internal, external and supplier audits
• Manufacturing and process quality
• Validation and qualification
• Preparation and support for certification and regulatory audits

Experience

My experience within Medical Devices ranges from setting up an ISO 13485 QMS and supporting certification by a Notified Body, to operational Quality within Class III Medical Device manufacturing. I have worked on QMS harmonisation, NC/CAPA, root cause investigations, audits, supplier quality, validation and QC leadership. This enables me to support organisations with both the further development of their quality management system and operational quality challenges.