Experience

JEB Technologies Ltd

• United Kingdom
• Industrial Machinery Manufacturing
• 1 - 100 Employee

• Medical Regulatory & Quality Assurance Engineer

  • Mar 2018 - Present

  - Auditing of vendors and subcontractors in line with ISO 13485 and or ISO 9001 requirements. Keeping the approved supplier listing and supporting documentation current. - Provide support with generating documentation relating to the technical file and CE marking of medical devices. - Generating project documentation in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (MDR) and other medical device regulatory requirements. - Providing QA support for the implementation of ISO 13485:2016 and ISO 9001:2015. - Perform tooling and manufacturing validation assistance, when required. - Attend and organise customer meetings, when required. - Liaise with customer and suppliers to gather relevant project information. - Internal audits and supporting documentation can be accomplished. - Investigating and obtaining material safety evidence/ certificates of conformance. - Develop product test methods, basic data analysis and evaluation to determine or prove product conformance and safety. - To function within all regulatory requirements and quality systems, particularly related to medical devices. - Global and UK travel accomplished to satisfy the needs of the project. - Support given in setting up QA systems pertaining to both products and manufacturing equipment. - Monitors and provides guidance to controlled and or cleanroom environments.



Redbourn Engineering Ltd

• Mildenhall, Suffolk

• Senior Quality & Compliance Engineer

  • Jun 2015 - 2016

  - To ensure that Quality, Health & Safety and Environmental procedures and standards are enforced at all times by all staff. - To ensure the company is kept up to date with all relevant legislation and best practice. - Maintain the company's certification to ISO 9001 & 14001 and other standards as required. ISO 18001 is a future targeted objective. - Lead Auditor to customer or supplier audits, reporting, analysing and taking actions on findings. - To schedule, perform and or otherwise guide other internal auditors to audit the company against its own procedures and processes. - To represent the company in dealing with external bodies, suppliers and customers. - To work with all appropriate departments in the resolution of customer complaints. - Manage and administer internal/external product rejections and supporting documentation. - To organise and lead the process of management review for the company's systems. - Document, schedule and administer required training. - Perform and administer 5S activities and work with process/area personnel to achieve success in their areas.



JDR Cable Systems

• United Kingdom
• Oil and Gas
• 300 - 400 Employee

• Supplier Quality Engineer

  • Sep 2007 - Jun 2015

  - Performs quality Factory Acceptance Testing and or Witness inspections on products at JDR or supplier premises.- Trained Lead Auditor & Internal Auditor in ISO 9001 (QMS), 18001(OH&S) and 14001(EMS).- Responsible for supporting the purchasing department in dealing with non-conformance (NCR) issues raised during goods in, manufacturing, test and termination processes, where issues relating to suppliers has arisen. - Produced and maintain a supplier NCR database while having direct responsibility for the progression of all supplier related NCR’s ensuring compliance to the standards and requirements.- Evaluate all supplier related NCR's by investigating root causes and providing corrective and preventative actions.- Work closely with Purchasing and Supplier Development Manager to ensure approved supplier list is maintained and supplier's are evaluated.- Directly engage with suppliers to provide solutions prior, during and after product procurement. - Maintain communications with suppliers by attending their premises. These visits include performing audits and investigating product discrepancies as well as working with suppliers to produce and provide quality products to JDR.- I also provide coverage to my past position at JDR carrying out Fibre Optic testing,Power Core testing and all related inspections within goods inwards when required.

• Inspection Technician

  • Sep 2007 - Aug 2011

  Inspection Technician -- Goods Inwards.I performed test and conformance verifications of products manufactured by other companies as well as within JDR, materials purchased by JDR and free issue parts supplied by customers. Tests and verifications are performed in accordance with JDR purchase specifications, engineering drawings, inspection procedures, and quality plans. I prioritize my workloads by liaising with all departments within JDR.Inspections I perform are visual, electrical, optical, dimensional and documentational. Inspections I perform are on power cores, fibre optic cables, hoses (ID and OD), metalwork and all other raw materials. I use micrometers, calipers, ohmmeters (current resistance), Megger MIT525 5kv Insulation Tester (insulation resistance), Tektronic 1503B metallic TDR cable tester, Noyes M200 optical time domain reflectometer (OTDR) and JDSU MTS6000 OTDR and other measurement equipment. I ensure documentation (electronically or paper form entries) of testing or verification of results are processed in a timely manner. Responsible for raising and tracking Non-Conformance Reports, Deviation Concession Requests and Technical Query Forms. As I manage my own systems, I ensure reports are actioned in an effective and timely manner. All inspections are documented within excel programs. I also manage my own calibration requirements. I review product conformance certification, supplier test and dimensional data, welding and non-destructive testing documentation.Qualified forklift driver on a flexi truck and up to 28tonne forklifts, including banksman qualified