John Wallace Email & Phone Number

Cork, County Cork, Ireland

• Lead the implementation of QMS and ISO 9001 Certification in Mainland Europe, ensuring adherence to international quality standards.
• Conduct internal audits of Ireland, UK, and Mainland Europe sites to maintain compliance with ISO 9001 and company standards, proactively identifying and addressing quality issues.
• Develop and implement quality assurance policies and procedures, fostering best practices and a focus on quality throughout the organization.
• Manage CAPA process and work with departments to implement Process Improvements identified.
• Evaluate products, processes, and data to improve customer experience and regulatory compliance continuously.
• Provide training and guidance on quality processes, standards, and regulations, empowering teams and promoting knowledge sharing.

County Cork, Ireland

• Crest Solutions delivers machine vision inspection and track & trace solutions to packaging and manufacturing sites in regulated industries, such as pharmaceuticals and medical devices.
• Work with customers and internal team of engineers to develop test and validation documentation for bespoke automated vision inspection, packaging and serialization equipment projects including URS, FS and User Manuals.
• Develop software test protocols and execute tests to an Agile framework
• Responsible for authoring validation documents including 21-CFR Part 11 Assessment, Design Risk Assessments, Functional Design Specifications, Traceability Matrices, Master Validation Plan and Validation Protocols.
• Provide validation input into all project phases from design through to the commissioning, qualification and execution phases of the project.
• Generate, execute, review and approve completed qualification and validation protocols, reports and associated data for conformance to regulations, SOPs, specifications, customer expectations, internal company.

Cork

• Manage the costing and coordination of time and cross-functional resources for validation projects. This included the authoring and execution of Master Validation Plan, Risk Assessment/GxP assessment,VP, URS, TM.
• Liaise with operations and finance to ensure that costing is allocated to correct business cost center.
• Develop standard times and costs for new products.
• Manage the development, cost and supply of new consumables.
• Manage the production and scheduling of new product production through to completion by coordinating with key stakeholders (Validation, Design, Operations, Finance).
• Lead NPI development requirements and work with cross-functional teams in the Innovation Centre and with Value Streams.

Cork

• Create Project plans and successfully manage each opportunity to completion.
• Day-to-day support and resolution of any equipment or process related issues.
• Technical lead for manufacturing area
• Gage development, design and validations for inspections processes
• Support process project and lean optimization,
• Apply lean initiatives and Six Sigma tools to standardise problem resolution and development of more robust processes.

Cork, Ireland

• Work with a Manufacturing Team to improve KPIs and resolve issues
• Implement Electro-Mechanical solutions to improve KPIs
• Work with Toolroom and Vendors for solutions to issues and improvements to KPIs including creation and updating of Drawings according to cGMP.
• Use Problem Solving and Six-Sigma Tools to resolve day-to-day issues.
• Troubleshoot and setup machinery and escalate to Maintenance or Calibration Department when required.
• Function as support for continuous improvement projects using 6-Sigma/Lean Tools.

Haina, Dominican Republic

• Support Project Lead in all technical aspects of this highly complex Manufacturing Operations transfer from the UK to the Dominican Republic.
• Support dismantle of Medical Device Machinery in Convatec, a Multinational Medical Device Company in the UK.
• Ensure full inventory of parts and required consumables is compiled and liaise with shipping to ensure correct shipping.
• Support re-assembly of machinery in Nypro, Haina, Dominican Republic.
• Support IQ, OQ and PQ activity in order to ensure release to manufacturing within project dead lines.
• Debug and resolve issues where necessary and escalate to Maintenance or Engineering department when required.

Waterford

• Develop and Implemented a Spare Part Inventory Database and Issuance System
• Develop Spare Parts Procedure and train Maintenance and Process Technicians
• Issue spare parts when required.
• Order replacement spare parts to ensure spare part stock is maintained.
• Support Manufacturing Engineering in identifying improvements to parts and sourcing of improved parts
• Coordinate repair and refurbishment of parts.

Waterford, Ireland

Ensure Equipment Set-Up Correctly for OperationInspect Equipment for potential EH&S IssuesEnsure Maintenance, Calibration and Service of Equipment has been carried outReport Line Down and Maintenance IssuesStatistical Process Control Product Testing and SamplingTrained in Ford Production Systems

Portlaw, Co. Waterford

Ensure Equipment Set-Up Correctly for OperationInspect Equipment for potential EH&S IssuesEnsure Maintenance, Calibration and Service of Equipment has been carried outReport Line Down and Maintenance IssuesLeather Grading, Testing and Sampling

Nfq Level 8 Certified Diploma In Project Management, Project Management

Bsc (Hons) Advanced Manufacturing Technology

Engineering Project Management Mathematics - Probability and Statistics Quality Engineering Automation Systems Advanced Materials &.

National Certificate In Manufacturing Technology, Manufacturing Technology

Computer Science Electronic Science Electrical Science C++ and Visual Basic Programming PLC Programming Automation and Control SCADA

National Certificate In Industrial Computing, Industrial Computing

C++ Programming Computer Science Electronic Science Communication Technology

Leaving Certificate

Mathematics, Biology, Physics, Chemistry, English, Art