• 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.• Conduct Supplier Quality Assessments and assist with Customer Quality Audits• Conduct QA Review of Validation and QMS Documentation

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 (FAT, SAT, IQ, OQ, PQ) to GAMP5, Eudralex and 21 CFR standards• 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 standards, current industry practices and other applicable acceptance criteria. • Provide technical writing support to Quality Department for Deviations, CAPAS, and Change Controls which are associated with validated systems. • Provide technical input into update and creation of SOPs and Work Instructions.• Responsible for reengineering documents to meet current specifications and good documentation practices. • Co-ordinate validation documentation review and approval. • Conduct training sessions for other team members on documentation standards and other topics relating to validation, risk and compliance.

• 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, IQ,OQ,PQ protocols, and Final Validation Report.• 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.• Provide design for manufacturing technical input to global design groups to minimise lifecycle cost.• Deliver stable manufacturing solutions in line with stability metrics process.• Management of R&D test parts and sample requests.• Manage risk and validation lifecycle for new processes and process changes.• Management of the Asset Lifecycle for new equipment (URS/RA/IQ/OQ/PQ).• SME and Training facilitator for Drag Polishing (Rossler), In Process Cleaning (Mecwash) and Milling (Mazak).• Provide timely and accurate reporting on project activities.• Kaizen Champion for Project Group

• 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.• Design and guide implementation of Electro-Mechanical solutions working with Toolroom and Vendors for KPI improvements including creation and updating of Drawings and creation and exection of validations (IQ, OQ, PQ etc).• Complete process characterizations in advance of any validation activities• Generate validation protocols and reports to support validations• Support validation executions, IQ, OQ, PQ, and TMV/Gage R&R’s• Core team member for manufacturing cell to attain Shingo prize• Monitor and report Yield on a daily basis in collaboration with Process Technician and work with Line Support Team and Product Builders to resolve any issues. • Lead or support in resolving any material issues. Escalate and liaise with Supplier Quality when required up to and including escalation and creation of SCAR .• Lead or support remediation of CAPAs and NCRs.• Support maintenance to resolve machinery issues or improvements. • Identify and implement maintenance improvement opportunities.

• 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. • Monitor and report Yield on a daily basis and work with Line Support Team and Product Builders to resolve any issues. • Support resolution of material issues• Support execution of IQs, OQs and PQs where and when necessary• Support remediation of CAPAs and NCRs.• Support calibration and work with calibration technicians to resolve issues such as calibration deviations.• Support maintenance to resolve machinery issues or improvements. Identify and implement maintenance improvement opportunities.

• 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.• Train Operators and Process Technicians in Dominican Republic on use and maintenance of machinery. • Train Operators and Process Technicians in cGMP and ensure that it is adhered to at all times

• 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. • Support Lean - High Velocity Projects• Work with Engineering and Vendors in identifying suitable spares an improvements to existing spares.• Monitor and report Spares usage against Budget

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

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