Stephen Hunter Email & Phone Number

Responsible 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.

Cheshire

Responsible 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.

Manchester, United Kingdom

Key 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.

Winsford

Responsible 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.

Winsford

Currently 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.

Warrington, United Kingdom

Coordinated 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.

Warrington, United Kingdom

Worked 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.