16th January 2023
Olympus are recruiting
Olympus, based in St Mellons, have several new job vacancies available.
To view the full job descriptions and to apply, please click here.
The successful applicant will perform quality engineering activities to support safe, effective and compliant sustainment of the organisation’s medical device designs and manufacturing processes.
Execute procedures regarding quality planning, design control, process control, verification and validation to aid delivery of efficient designs and processes which provide safe, effective and compliant medical devices
Review and approve product and process documentation throughout entire product lifecycle to ensure compliant, effective and suitably robust design solutions are fully documented
Ensure risk management procedures are fully applied identifying product and process risks and that risk mitigations are implemented so as to ensure safe and compliant medical devices
Support legal manufacturers documentation requirements and technical enquiries to demonstrate company’s state of the art regulatory solutions for applicable markets
Apply statistical analysis procedures to product and process data during design, verification, validation and post launch to provide objective, data based analysis and conclusions
Support the application of problem solving tools, to achieve documented resolution of technical issues affecting the product or process
Senior Quality Systems Engineer
The successful applicant will be responsible for the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and Good Manufacturing Practice
Support established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaints, Post Market Surveillance, Non-conformance Report (NCR), Document Control, Incoming Inspection and Product Release.
Participate in the interpretation of EU and US regulatory Requirements to produce effective working policies and procedures.
Provide effective solutions/advice to design and manufacturing teams on established procedures to ensure products are designed and developed and manufactured according to the requirements of the relevant regulations
Manage and conduct internal and inter-company Quality System Audits with responsibility for the audit process lifecycle.
Ensure the timely progression of improvement activities resulting from audit findings.
Support second and third party audits of OSTE.
Analyse data, including the use of statistical techniques, to provide reports to management to enable them to monitor system performance.
Review and authorise documentation and processes in the Quality Management System to ensure compliance with established quality procedures and applicable regulations and alignment with other related documentation.
Identify and collaborate in the implementation of changes to the Quality System to increase efficiency and/or effectivity whilst ensuring compliance with applicable regulations.
Supervisory/deputising duties for other team members, as required.
Support and perform training throughout the company to maintain awareness of the Quality System requirements
Vendor Quality Engineer
Perform supplier quality engineering activities supporting safe, effective and compliant development and sustainment of the organisations medical device designs and manufacturing processes
Establish, maintain and execute the means of evaluating, including site auditing, and approving; the quality/regulatory aspects of vendors to maintain a compliant approved external supply base in the best commercial interests of the company
Co-ordination, review and approval of internal and external component qualification effort, including coordinating conduct of; metrology, measurement system analysis and capability assessments; to ensure ongoing confidence that all externally supplied componentry meets predefined design requirements, in a compliantly documented manner
Co-ordinate the supplier corrective action request system to ensure the timely resolution and closure of vendor related quality issues
Support vendor communication and improvement activity, using problem solving tools, to continuously improve the quality and cost of vendor supplied product and service
Compile metrics relating to vendors quality performance; to support provision of vendor performance analysis to top management