Experienced Quality professional specializing in radiation sterilization of health care products. Development and management of validation and routine control of radiation sterilization processes in accordance with BS EN ISO 11137 & BS EN ISO 11737. Defining and documenting methods for establishing sterilization dose requirements and confirming the continuing suitability of the established dose. Ensuring product sterilization undertaken by gamma sterilization providers is performed according with appropriate regulatory authorities requirements. Demonstrated history of working in the medical device and IVD industries. Skilled in Project management, transitional projects, QS implementation projects, Gamma Radiation Sterilization and Validation, Root Cause Analysis, SOP Development. Extensive industry experience supporting New Product Implementations, leading Risk Management activities and assisting Design & Development activities. Strong quality assurance professional with a proven track record of delivering quality projects and improvements to a high standard.
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Design Assurance ManagerConvatec Dec 2021 - PresentResponsible for managing projects and a team of Design Assurance Engineers that support Design & Development projects as well as supporting the maintenance of Design Controls throughout the product lifecycle. -
Managing Director At Quality Consultancy ServicesQuality Consultancy Services Feb 2019 - PresentCheshireResponsible for ensuring that Design Control requirements meet regulatory and applicable procedural requirements. Contributes to Development of new products within the new product development process. Reviewing and approving design control document outputs. Leads, facilitates and participates in Risk Management activities to support product development and post launch change control activities. Responsible for Post launch reviews, investigates product/process performance issues and evaluation of products. Facilitates and participates in validation activities of production mould tools for the production of injection moulded plastic components.
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Quality Assurance SpecialistWaters Corporation Aug 2017 - Jan 2019Manchester, United KingdomKey responsibilities include:ISO 13485:2016 gap analysis and transition strategy for Waters Wilmslow.AS9100-ISO9001:2015 supplier gap analysis and transition strategy.Develop, implement and maintenance QMS in accordance with ISO 13485:2016, ISO 9001:2015, 21 CFR Part 820 and IVD Directive 98/79/EC.Establish and implement necessary communication strategy for ISO 13485:2016 transition plan.Manage the QMS for compliance, solicit and suggest methods for improving compliance while interacting with internal stakeholders.Ensure key business processes are identified and documented at an appropriate level, including key processes such as management review, internal audits, CAPA, change control, NCR and continuous improvement. Recommend, implement and direct others to modify operational methods and practices along with overall strategy to enhance effectiveness.Ensure future activities are in compliance with applicable regulatory requirements and company quality assurance standards. -
Sterilisation Project EngineerAdvanced Medical Solutions Dec 2015 - Jul 2017WinsfordResponsible for the development, validation and routine control of gamma radiation sterilization process for wound care medical devices in accordance with ISO 11137/ISO 14937 & ISO 11737. Defining and documenting methods for establishing sterilization dose requirements and confirming the continuing suitability of the established dose. Ensuring product sterilization undertaken by gamma sterilization providers is performed according with appropriate regulatory authorities requirements. Responsible for the development and implementation of unique device identifier label (UDI) for medical devices at AMS. Ensuring labelling of medical devices fulfils the statutory and regulatory requirements of FDA 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 822 and 830. -
Product Quality EngineerAdvanced Medical Solutions Nov 2014 - Dec 2015WinsfordCurrently working to support the achievement of measurable continual improvement and quality and regulatory compliance within a medical device company. Working with manufacturing, supply chain, quality departments and R&D to support new product introductions, progress change requests, identify and evaluate product and process risk through the application of medical device risk management requirements. Reduction in product, process and quality management system non conformance's and complaints. Working knowledge and experience in developing and manufacturing product in a regulated environment cGMP, CFR 21 Part 820, MDD 93/42/EEC, ISO13485 and ISO9001.
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Lead Manufacturing SupervisorThermo Fisher Mar 2014 - Nov 2014Warrington, United KingdomCoordinated activities in production areas to meet production goals, quality requirements and cost objectives including the management and deployment of personnel across all work areas and production schedules. Communication of key performance indicators and financial numbers internally as well as externally. Lead meetings involving analysis of performance, development of solutions and implementation of corrective actions. Understanding of necessary business systems and tools to enable competent decision making and reporting. -
Senior Manufacturing TechnicianThermo Fisher Feb 2010 - Mar 2014Warrington, United KingdomWorked as part of a high throughput manufacturing team at Thermo Fisher Warrington. Extensive knowledge and experience of development and manufacturing in a regulated environment (IVD). Bespoke manufacture of consumable IVD products produced by synthesis, formulation and QC testing of product according to set procedures with due regard to product availability and integrity. Extensive practical and theoretical knowledge of plant operations, manufacturing techniques, processes and associated analytical methods such as formulation chemistry, HPLC, PCR, GC, UV-VIS, FTIR and protein sequencing.
Stephen Hunter Skills
Stephen Hunter Education Details
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Liverpool John Moores UniversityNatural Sciences
Frequently Asked Questions about Stephen Hunter
What company does Stephen Hunter work for?
Stephen Hunter works for Convatec
What is Stephen Hunter's role at the current company?
Stephen Hunter's current role is Design Assurance Manager Convatec.
What schools did Stephen Hunter attend?
Stephen Hunter attended Liverpool John Moores University.
What are some of Stephen Hunter's interests?
Stephen Hunter has interest in Science And Technology, Education, Environment, Health.
What skills is Stephen Hunter known for?
Stephen Hunter has skills like Medical Devices, Iso 13485, Quality Assurance, Fmea, Process Improvement, Process Flow Charts, Cgmp Manufacturing, Iso 9000, Iso 14971, Auditing, Internal Audit, Supplier Quality.
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