Keith Knight (He/Him/His) Email & Phone Number

Oxford, Oxfordshire, Gb

Crawley, England, Gb

SQA documentation updates for group level, MDR & MDSAPLed supplier surveillance audits rationale, audit plan, leading audits (ISO9001 & ISO13485), reporting, CAR management, budget etc.Developed supplier performance reporting system for quality and delivery metrics. Supplier development activities including basic quality tools training, conveying MDR expectations, NC closure expectations etc. Charing weekly quality review meetings with poor performing suppliers.Supporting clients ISO13485 NB surveillance audit. Coaching the internal team members in the skills required to effectively manage suppliers, audits. workload, priorities etc. Supporting / stabilising the department through transition of 4 changes in department head.

Oxford, Gb

NPI, SQA, Supplier Development, QMS, Equipment & process development, diagnostics, IVD, Manufacturing Engineering and Quality activities for the production department. Developed and implement assembly line improvements, led design of new assembly jigs, led design and implementation of robot assembly station, led the team though major quality investigations for variability reduction, sourced and implemented electric presses, development of assembly work instructions, coaching and mentoring for the team.

Croydon, Gb

Responsible for supplier related activities to drive down the number of open supplier quality complaints and audit compliance issues.Developed supplier performance reporting system for quality and delivery metrics. Supplier surveillance audits rationale, audit plan, leading audits, reporting, CAR management etc.Supplier development activities including basic quality tools training, conveying MDR expectations, NC closure expectations etc. Charing weekly quality review meetings with poor performing suppliers.Supporting clients ISO13485 surveillance audit. General QMS document reviews, updates, improvements etc to improve clarity, efficiency and compliance.Coaching the internal team members in the skills required to effectively manage suppliers and audits.

Abingdon, Oxfordshire, Gb

Development of streamlined IQ, OQ, PQ validation plan, protocols and reports for revised production process. DMR, DHR, Manufacturing Instructions, Process Flow Diagram & PFMEA creation. Lead the implementation of continuous improvements to manufacturing and support processes including rework, labelling, goods inwards, calibration, training, purchasing.Supporting new product introduction processes, FAIR and component sourcing.

Kidlington, Oxfordshire, Gb

Kidlington, Oxfordshire, Gb

Responsible for all aspect of quality in the moulding department. Representative at daily and weekly SMT and Customer meetings. Leading the drive for compliance to Customer standards, internal systems and processes and the drive towards IATF16949 transition within the mould shop. Development of the quality team for use of 8D methodology, document and data control, gauge studies and ongoing use, general use of quality core tools and defining clear roles & responsibilities.

Responsible for leading the department I had previously worked in (Dec-12 – July 15). Developing KPI’s and data collection processes, recruitment of new section leaders and team leaders and the development of the existing team. Leading weekly review meetings and conference calls for multiple customers. Development of the systems & processes to aid the production department to meet KPI targets. Responsible for being the voice of the process for design reviews, new programs, process and product change process and continuous improvement activities. Additional tasks included leading validations for new/replacement production equipment, leading change controls for process, product and packaging specifications, leading departmental drive for compliance to SOP training, internal & external audit success, customer satisfaction and successful team personal development.Whilst handing over to a new permanent production manager (June 16) additional responsibility for the Operational Project Management of the cold chain manufacturing/supply systems and infrastructure for a Home Office classified Controlled Drug Auto-injector through Clinical trials. Chairing weekly project industrialisation meetings to allocate resources and priorities to drive readiness for clinical trial device manufacturing. Home office Controlled Drug licence, MHRA (IMP) licence and FDA submission support activities for US based Customer. Key Skills - Production, Quality, Projects, NPI, cGMP, Validation (URS, FAT, SAT, IQ, OQ, PQ), Packaging development and approval, Labelling development and approval, CAPA, Investigations / problem solving, Supplier CAPA, PFMEA, DFM, DFA, Design Review, Lessons Learned reviews, recruitment, ISO13485 environment, Combination product, Injectable, Sterilisised product, Combi-product.

Responsible for leading the quality department during the final pre-production and launch phases of two simultaneous product lines for prestige OEM Customers. Development of the departmental headcount plan, roles and responsibilities and activities to meet both internal and external Customers requirements. Voice of the customer internally on all matters relating to product and system quality. Development of KPI’s and implementation of QOS to drive continual improvement. Implement systems of data collection, monitoring and action from Customer concerns, Internal concerns, CMM and manual gauging processes.Key Skills – Quality Management, Metrology, Quality Planning (APQP), Customer Management, Supplier Management, Resource allocation & prioritisation, recruitment, Honda QAV, Ford Run @ Rate, PQCT, Control plan, PFMEA, FMS, Machining, TS16949 drive/support

Responsible for the manual assembly departments main product line. Leading daily production meetings and weekly customer review meetings. This role involves driving component quality & supply both internally & externally, driving production of devices and CI activities, ensuring the customers quality & delivery requirements are met and exceeded where possible. This role also includes detailed data driven investigation and root cause analysis, report writing and driving the implementation of agreed corrective actions. Key improvements are the development and implementation of my CI strategy including production line changes working towards a single piece flow principal, component supply improvements and eliminating waste in the value stream including elimination a 5 day night shift whilst achieving record levels of production since July and exceeding all of the quality expectations set by the customer. Currently leading the decommissioning plans and implementation to meet client and customer requirements to conclude production in 2015. May 15 Update – Transferred from Production to Supply Chain to conduct the same Customer focussed role but with different Customer and with a supply chain focus. Intent was to improve delivery performance and therefore Customer satisfaction. Dashboard developed to measure and monitor improvements in performance from supplier focus, planning activities and inventory management. Leading weekly customer conference calls reviewing production improvements, supply status, new project status and act as “voice of the Customer” internally.Key Skills - Production, Quality, Projects, cGMP, Validation (URS, IQ,OQ,PQ), CAPA, Investigations / problem solving, Supplier CAPA, PFMEA, Lessons Learned reviews, Decommissioning, Supply Chain, MRP, ERP, ISO13485 environment

Leading the UK team for the re-introduction of an after sales seatbelt assembly for JLR / Unipart. Managing FMEA, Production readiness & Assy instructions, SREA, PPAP, ISIR’s and supplier quality.Additionally responsible for the current production project quality activities including customer support visits, concern investigation & resolution, driving manufacturing team in concern management and being a communications link between the customer (JLR) and the design/engineering teams in Germany. Regular representative at customer reviews including Complex Quality Meetings and “Seniors Review”.Key Skills – Quality Management, Metrology, Quality Planning (APQP), Customer Management, Supplier Management, Investigations, Quality Tools, JLR systems, LRR, Control plan, PFMEA, Seating, Design Review, PPAP

Management of all departmental “exception documents”. This includes detailed investigation and root cause analysis, report writing and driving the implementation of agreed corrective actions. Identification and implementation of departmental continual improvement projects. Technical Support for NPI team for problem solving reporting. Representing the moulding department in customer meetings relating to concerns or continual improvement activities.Key Skills - Quality, Production, Projects, cGMP, CAPA, Investigations / problem solving, Compliance, Quality Systems (ISO13485), 5S, CI packaging, process, layout changes, Change Control

Responsibility for 2 new Jaguar seating programs in Launch phase and 6 new programs in development phase. Leading the development of “issues lists” and driving weekly progress meetings. Leading reviews with Jaguar quality for project approval status. Development of process documentation including PFMEA, PFLOW & Control Plans. Responsible for Customer quality issue resolution (AIMS) with weekly progress meetings with customer. Driving all new project pre-production trials across 2 shift operation to ensure all quality verification happens, build issues are logged and final seat approval to ship. Supporting new quality department employees by mentoring them based on my work ethic, knowledge and experience.Key Skills – Quality Management, Metrology, Quality Planning (APQP), Customer Management, Supplier Management, Investigations, Quality Tools, JLR systems, LRR, Control plan, PFMEA, Seating, Design Review, PPAP, “Perceived Quality”, QMS - TS16949 support

Management of the overall customer account for issues relating to quality. Development of the project plan and implementation. Driving and supporting all areas of the business from shop floor associates to Executive level to hit commitments made to the customer. Chairing of weekly customer conference call, driving improvements across the business and supporting the drive for culture change through leading by example, working with individuals 1:1 and showing a can-do flexible approach. Supporting update of QMS, development of cGMP principals and implementation of departmental KPI’s. Driving external audit corrective action planning and reporting back to customers. Supported the development of a revised supplier management strategy to be implemented Q3 2010. Supporting / driving CAPA activities to meet customer expectations whilst ensuring compliance to ISO13485, CFR820 and internal systems requirements.Key Skills – Quality Management, Project Management, cGMP, CAPA, Investigations / problem solving, ISO13485 QMS development, Customer management, External Audit, Customer Audit

Management of the quality department whilst driving robust resolution of customer concerns. Engineering change control in plant to reduce obsolescence, stock management and timely implementation. Supplier concern management and reporting. Re-developing all production work instruction documentation, control plans, CRT’s & PFMEA’s. Customer facing role supporting the continual improvement of plant performance. Support to the Quality Manager for pending TS16949 audit. Developed supplier management system with assessment questionnaire, monthly monitoring, general supplier development and drive towards to ISO9001.Key Skills – Quality Management, Metrology, Quality Planning (APQP), Customer Management, Supplier Management, Investigations, Quality Tools, Control plan, PFMEA, Injection Moulding, Design Review, PPAP, Bentley, Automotive Bumpers, QMS - TS16949 support

Management of JLR customer concerns. Driving root cause analysis, corrective action and customer reporting. Engineering change control in plant to reduce obsolescence, stock management and timely implementation. Supplier concern management and reporting. Re-developing all production work instruction documentation, control plans, CRT’s & PFMEA’s. Customer facing role supporting the continual improvement of plant performance. Support to the Quality Manager for pending TS16949 audit.

Working with SME’s in the South West region for development, implementation & auditing of systems for ISO9001:2008. As part of the working partnership Business Improvement Techniques have been employed to provide additional benefits to the client. This has included tools such as 5S, 8D, VSM, Technical training, and development of KPIs.

Burgos, Spain, Es

Supporting Oxford plant in the de-escalation process with BMW. Development of the de-escalation plan including KPI’s, simple but robust management systems, implementation of immediate robust containment actions and the subsequent Corrective /Preventative actions (Poka-Yoke where possible). Customer support for quality and engineering issues. Driving concern resolution with Customer (PQM) and Supplier. PPAP preparation and presentation including development of key suppliers PPAP’s. Daily reviews and improvement activities with BMW QMT, Production & Purchasing departments.

Munich, De

Responsible for all door and seating issues on Mini & Mini convertible (R52 & R56) from a warranty perspective. Analysis of dealer returns and reports, working to identify root cause of the issues and then ensure robust corrective action implemented to resolve the issue. This meant driving other departments including assembly, SQA (QMT) and product engineering via review meetings and the BMW PQM system. The process of problem solving includes supplier audits, process reviews, chairing complex technical reviews, communicating with suppliers & BMW senior management and formally presenting issue status to senior management within BMW

Concordville, Pa, Us

Covering all aspects if quality from adherence to internal APQP systems, supplier development and SQA, Customer facing including PPAP, timing plan presentation etc etc. Involved in new product development and testing of an automotive tier 2 supplier of glove box latches. Customers included Fiat, Porsche, Scania, Ford, SAS & Intier.

Initial role was to manage the quality aspects of Telford plant closure and transfer into Leamington. This involved extensive customer and supplier liaison for planning, timing and APQP / PPAP activities.Second role was AQE for Headliner program for LRV. Responsible for all customer and supplier APQP & PPAP activities. Included activities were gauge design and procurement, tooling approval, monitoring of the program adherence to JCI systems, product capability analysis, design reviews etc.Current role is the same as above but on a TMUK program.

Management of the site quality department. Customer Quality, Supplier Quality, QMS, developing all production work instruction documentation, control plans, PFMEA’s, PPAP’s etc. Customer facing role supporting the continual improvement of plant performance metrics

Burgos, Spain, Es

Customer facing QE responsible for all concern investigation, containment and corrective action including daily FCPA feedback to LRV Senior management. Responsible for achieving a level of stability on the customer site to allow plant to focus on permanent corrective action implementation.As Quality manager assumed responsibility for the plant overall performance, KPI monitoring, control plan adherence, etc to meet corporate expectations.Drive supplied part quality concern resolution.

Management of four UK sites for the ongoing accreditation to QS9000 & drive for TS16949Management of four UK sites for the ongoing accreditation to ISO14001 & OHSAS 18001Responsible for the day to day running of the plant Quality department on all sitesDevelopment of systems to identify KPI's set targets and systems for data capture & analysisDrive improvements in Customer satisfaction including OEM, Auditors, HSE, Environment Agency and Local Councils.Drive improvements in supplied part quality and supplier liaisonImprove the synergies in systems used across the four sites.Involvement in new product introduction driving the use of APQP techniques

Management of Quality department including Engineers, Goods In, Dock Audit and Laboratory functions. Responsible for ongoing compliance to QS9000 & ISO 14001 Customer liaison activities not only for Quality Issues but for PPAP approvals, drawing changes etc. Supplier management to eliminate quality & supply concerns and to develop systems where required.Responsible for developing the current Engineering change system to be a Change Management System for process, product, supplier changes etc.Key member of the management team and so involved in all major decision making, strategy reviews etc.

Us

Management of two key customers Honda & IBC whilst supporting all other customers as required.Employed to develop the quality system & take the company through their Triennial QS9000 review.Developed the use of QOS in the plant for Scrap reduction activities & provided training where required.

Management of 20 Quality, Engineering & Maintenance personnel. Responsible for JIT plant and new program quality in terms of supplier APQP & management, production quality & processes and customer quality. Management of engineering change & implementation into JIT. Responsible for Quality system development, implementation & conformance.Key member of the management team therefore involved in all strategic planning & decisionsResponsible for quality of production start-up of three new products all being JIT & synchronised manufacture.With Operations manager responsible for plant construction, equipment sourcing & manufacture & process layout & installation.Made redundant

Cork, Ireland, Ie

Responsible for all aspects of program quality on Jaguar X400 interior parts including, Supplier APQP, Customer APQP, Customer concern resolution and conformance to procedures. Management of 3 engineers acting in an advisory capacity to ensure standardisation across all new programs. Involved in ensuring compliance to the quality strategy of program management. Responsible for producing all PFMEA’s, C/Plans, P/Flows etc

This position gives responsibility for all aspects of Honda business. This includes customer liaison at all levels on matters of a quality, commercial, logistics and production nature.Responsible for the smooth introduction of all new projects that involves production team training, supplier development and ensuring the manufacturing plant is totally ready for mass production launch including D/PFMEA, FTA, Capability and Capacity studies etc. Responsible for the maintenance of ISO 9002 system and the drive for QS9000 accreditation due May 99 including carrying out internal audits.

Responsible for quality and inspection of all parts in the cell. Liaison with customers and suppliers at all levels. Customers include Ford Southampton, Genk and Cologne. Instrumental in the company achieving Ford Q1 status. Responsible for the development and updating of all FMEAs, Control plans and SPC.Investigating potential failure modes on new projects to eliminate potential quality problems.Reporting to Group Directors on matters of a quality nature.Responsible for the team if inspectors and their day to day management.

Gb

Responsible for the dimensional checking of all types of vehicle produced, sub-assemblies and any other dimensional measurement required for quality problem resolution. This involved checking of bodies from development stages through to mass production. The main equipment used was a computer controlled 3D measuring machine. A CADDS4 terminal and various PCs were used to confirm CAD data prior to the checks, to produce programs and inspection reports.In April 92 I worked in Japan with Honda to approve tooling for Rover 600.

Gb

During this apprenticeship various skills were obtained in many areas including:- Press Shop, Machine Shop, Body-In-White Assembly, Paint Shop and Pipe Fitting Department.