Job Overview

Based at our Bourton-on-the-Water site and reporting to the RA/QMS Manager, the post holder will provide day to day management of the document control and associated training processes across the business. This will be carried out using an electronic document/training management system (EQMS) as well as providing administrative support to the RA department.

Duties will include:-

• Maintain the document control and associated training processes through the day-to-day management of the electronic quality management system (Master Control); processing procedure changes and company-wide process improvements.
• Support Colleagues in their day-to-day use of the electronic quality management system (Master Control) and provide training to new starters as required.
• Contribute to the development and implementation of additional modules in the electronic quality management system (Master Control) as the system is expanded.
• Collate, analyse and distribute data for department and business KPIs and metrics.
• Provide support during external audits and inspections.
• Support the planning and completion of internal quality audits.
• Provide general administrative support.

Applicants should have previous experience in an administrative role and be confident in the use of IT systems/platforms including excellent working knowledge of Microsoft Office applications.  A high level of attention to detail is essential for this role. Experience with a document management system, working in a regulated industry and an understanding of Quality Systems (e.g. ISO9001, ISO13485) is desirable but not essential. 

The successful candidate will enjoy a competitive salary, AVIVA Group Personal Pension Scheme with matched contributions, BUPA Private Healthcare, flexible working arrangements, a modern office space and other exciting benefits.

If you think you are the right person for this role please send your CV and covering letter explaining why you wish to be considered to: RECRUITMENT@SUMMIT-MEDICAL.CO.UK

Based at our Bourton-on-the-Water site and reporting to the Head of Operations. The Engineering team provide manufacturing engineering and technical expertise and support to Operations, to the New Product Development and Innovations team and to the wider business.

The Engineering Manager will coordinate the activities of a team of 3-6 employees. In addition, they will utilise their own expertise to provide, maintain, and seek to continuously improve cost-effective and Good Medical Practice compliant manufacturing processes, procedures, equipment, and tooling solutions on behalf of Summit Medical.

Duties will include:-

• Provide leadership of all manufacturing engineering activities and processes.
• Lead the preparation of capital and project equipment and tooling budgets, and the delivery of investment and expenditure plans.
• Assist the Head of Operations to develop and deliver short, mid and long-term departmental goals and objectives in support of Operational goals and Business Objectives, and establishing meaningful, associated KPI’s.
• Manage the specification and procurement of new or replacement injection-mould tooling, manufacturing equipment and jigs-and-fixtures.
• Support the Operations team and suppliers in problem-solving and resolution of product and component quality concerns and in the implementation of engineering and process changes:
• Provide mentoring and coaching to develop the technical expertise and competence of the Engineering team.
• Provide leadership in the application of continuous improvement tools and techniques for problem-solving, planning and implementation of initiatives to increase efficiency, reduce waste and improve the safety of manufacturing processes and equipment.
• Support NC/CAPA process and to conduct periodic review of the effectiveness of processes and procedures related to Engineering tasks
• Investigate and promote the adaptation of best-practices and technical innovations within the medical devices manufacturing field.

Qualifications and Experience:

The successful applicant will have a degree, or high-level equivalent qualification, in a relevant engineering discipline along with at least 5 years relevant manufacturing engineering experience in a regulated manufacturing environment, preferably but not necessarily, medical devices. They should also have sound knowledge of polymer injection-moulding processes and tooling, and demonstrable competence in engineering project planning and execution, either in new product introduction or manufacturing equipment/process development. A high level of numeracy and literacy skills with competence in evaluating cost-reduction opportunities and capital investment justification are also essential skills 

Experience of working within ISO13485 Regulations, a history in the delivery of automation/autonomation solutions within a labour-intensive manufacturing facility, a track-record of the implementation of process innovation and/or continuous improvement within a manufacturing environment, first-hand experience of injection moulding of small thermoplastic components and tooling and experience of regulated, process validation techniques are all desirable. Previous supervisory/managerial experience and Mentoring or coaching experience (not necessarily in a work context) would also be advantageous.

The successful candidate will enjoy a competitive salary, AVIVA Group Personal Pension Scheme with matched contributions, BUPA Private Healthcare, flexible working arrangements, and other exciting benefits.

If you think you are the right person for this role please send your CV and covering letter explaining why you wish to be considered to: RECRUITMENT@SUMMIT-MEDICAL.CO.UK

The Engineering team provide manufacturing engineering and technical expertise and support to Operations, to the New Product Development and Innovations team and to the wider business.  We are seeking a Manufacturing/Tooling Engineer to join the team, based at our Bourton-on-the-Water site and reporting to the Engineering Manager.

Duties will include: –

• Lead manufacturing engineering for the delivery of new projects on time, and to budget for NPI and Operations. 
• Provide technical support for manufacturing operations including problem-solving and reactive first response to production difficulties.
• Manage the SML Tooling Portfolio to include oversight of maintenance and repairs to injection-mould tools in production at suppliers, jigs, and fixtures on-site at SML.
• Lead the specification, procurement, and implementation of new injection-mould tooling for NPI and delivery of a replacement/upgrade programme for existing component manufacture, in-line with budgets.
• Lead and support Continuous Improvement activities for Manufacturing to improve process yield, product performance, throughput, cost, and safety.
• Create, maintain, and review production documentation in line with Summit Medical procedures, good practice, and relevant standards.
• Support NC/CAPA process and the implementation of engineering and process changes.
• Support the operations team to deliver improvements to KPIs / metrics.
• Provide support for validation activities.
• Actively engage in and promote best-practice in Health and Safety.
• Any other duties considered commensurate with this position.

Qualifications and Experience:

The successful applicant will have an HND, Degree or equivalent experience in a relevant engineering discipline with a minimum 2 years’ experience working to international quality standards, preferably medical devices ISO13485. They will also have experience in light manufacturing assembly of plastic components and developing standard operation procedures, work instructions and other manufacturing documentation. An awareness of LEAN manufacturing tools and processes and competence in evaluating cost-reduction opportunities and capital investment justification are also essential skills.

Experience of working within ISO13485 Regulations, a history in delivery of automation/autonomation solutions within a labour-intensive manufacturing facility, a track-record of the implementation of process innovation and/or continuous improvement within a manufacturing environment, first-hand experience of injection moulding of small thermoplastic components and tooling and experience of regulated, process validation techniques are all desirable skills but are not essential.

The successful candidate will enjoy a competitive salary, AVIVA Group Personal Pension Scheme with matched contributions, BUPA Private Healthcare, flexible working arrangements, and other exciting benefits.

If you think you are the right person for this role, please send your CV and covering letter explaining why you wish to be considered to: RECRUITMENT@SUMMIT-MEDICAL.CO.UK