Careers
CURRENT VACANCIES
We are looking for a RA/Labelling Administrator to join us at our site in Bourton-on-the-Water. Reporting to the Registrations & Labelling Manager, the key responsibilities for the successful candidate will be coordinating the Packaging Artwork process to create/update labels, instructions for use and inserts by proactively liaising with internal and external stakeholders ensuring that all appropriate approvals are obtained prior to issue. On the job training will be provided.
Duties will include:
- Timely completion of all packaging artwork (labelling) creation and updates through the implementation of the company change control process, in accordance with the requirements of company SOPs/Procedures and recording of all updates on appropriate documentation.
- Provision of guidance and coaching to internal and external stakeholders as a labelling and artwork subject matter expert.
- Completion of all corresponding product change requests (PCR’s) for packaging artwork
- Proactively managing the existing packaging artwork / labelling.
- Managing all the administrative files for packaging artwork including the creative files and artwork archive.
- Following company procedures.
- Manage, maintain, and revise as necessary SOPs and other documents pertaining to packaging artwork.
- Support the Regulatory Affairs Department with any ad hoc requests as required.
Candidates should be an experienced and capable administrator with a high proficiency using Microsoft office and excellent written and verbal communication.
Successful candidates will be natural problem solvers with a can-do attitude. They will have a proven ability to develop and maintain effective working relationships with internal and external stakeholders and the ability to work independently in identifying and prioritising tasks.
A knowledge of graphics software package and previous experience of working in a regulatory industry is preferred but not essential.
The successful candidate will enjoy a competitive salary, AVIVA Group Personal Pension Scheme with matched contributions, 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
No experience necessary… you’ll be fully trained but attention to detail is essential. Candidates must be able to demonstrate a high level of accuracy in their work and recognise the need for product quality whilst attaining agreed levels of manufacturing efficiency.
The key purpose of this role is to assemble high quality medical devices to ship to hospitals around the globe.
We offer a competitive salary, a 4-day working week, excellent training and a friendly working environment.
Who are we?
Summit Medical are a successful and growing UK company based in Bourton-on-the-Water who design, manufacture and sell products used GLOBALLY for joint replacement surgery.
Help us deliver products that may be used on your family members.
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
We are looking for a Quality Engineer to join us at our site in Bourton-on-the-Water. Reporting to the Quality, Validation & CI Manager, the Quality Engineer is responsible for the monitoring and optimisation of product quality related processes and procedures across the business to ensure customer expectation is exceeded without compromising operational efficiency.
Duties will include:
- Investigation, root cause analysis and execution of corrections and corrective actions; as well as the Identification and implementation of preventive actions and improvements.
- Identification of ‘critical to quality’ aspects of products and processes and optimisation of appropriate, statistically valid, monitoring and controls.
- Support the establishment of appropriate calibration requirements across various inspection, test and production equipment.
- Ability to link the quality management system with operational objectives and deliver appropriate quality without compromising operational efficiency.
- Take an active role in the product release process, using recorded evidence to confirm medical devices have been manufactured, inspected and sterilised in accordance with pre-determined requirements and are eligible for release for sale.
- Champion the approval process of new product implementation/technology transfer.
- Drive quality and continuous improvement through the product development and production engineering processes, ensuring customer focus, capturing feedback and actioning lessons learned.
- Verification of work to pre-determined specifications and challenging those specifications through the communication of sound rationale when appropriate.
Candidates should have a degree and/or equivalent experience in an engineering discipline, experience in a quality role directly relating to manufacturing/production activities and in establishing metrics/KPls to drive manufacturing/production improvements.
Successful candidates will also have experience in the creation of standard operating procedures (SOPs) and work instructions(Wls), with quality management systems (ISO 9001 / ISO 13485) and also have project experience in a highly regulated industry. They will have robust technical knowledge (RCA/problem solving/CAPA/SPC/etc) and excellent communication skills; verbal, written and presentations.
Candidates will also have the proven ability to implement and sustain CAPA and improvement activities, along with knowledge, and/or experience, of processes supporting approval of suppliers and parts, and of Measurement Systems Analysis (MSA) activities. Experience with Six Sigma, Lean, TOM, continuous improvement type activities is highly desired.
Having experience with manufacturing processes, test/inspection and product auditing with exposure to complex products and assemblies would be a distinct advantage.
Experience in a medical device industry, with injection moulded parts and associated tooling, machinery and assembly and with equipment/process validation experience is preferred but not essential.
The successful candidate will enjoy a competitive salary, AVIVA Group Personal Pension Scheme with matched contributions, 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