Hannah Milward at CK Science is recruiting for a Quality Assurance Support Engineer to join a large multinational organisation involved in the treatment of musculoskeletal systems with products that include joint implants, trauma devices and biologic products. This will be on a contract basis for approximately 6 months at their site in West Yorkshire.
Please watch Hannah’s video below for more information on the role:
Job purpose:
The purpose of this Quality Assurance Support Engineer role is to provide quality engineering and process excellence support in a defined business unit / value stream environment for in-process, finished product, first articles & new product introduction.
Responsibilities:
Actively support all Compliance Initiatives with the value stream and plant
Actively support all defined value stream and plant goals and objectives.
Identify projects to resolve scrap, reprocessing and special causes that have a negative impact on value stream and plant goals and objectives.
Compile quality process specifications for new/transferred products/processes
Be responsible for the introduction and correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new products. Quality process specifications to be compiled for on site production and purchased for resale goods (Goods In Check procedures)
Reviews product designs, test protocols and co-develop critical characteristics/tolerances for initial testing and validations and subsequent routine manufacturing controls.
Assist and where appropriate lead in the compilation and execution of validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and materiel. Manage QA related change control for specific projects as directed
Participates in process evaluations (e.g. FMEAs).
Devises and implements methods and procedure for inspecting, testing and evaluating plans for subsequent routine production.
Support quality system activities within manufacturing cells such as Internal Audits, complaint investigations, close call and corrective action investigations.
Perform/document dimensional/visual inspections and non conformance and deviations as required
Manage a variable workload to meet operational requirements.
Ensure that all Health, Safety and Environmental requirements are fulfilled.
Competencies:
The ideal candidate for this Quality Assurance Support Engineer role will have the following competencies:
High attention to detail
Pro-active approach to work
High standards
Flexible
Excellent communication skills
Analytical skills
Team player
High level of numeracy
Highly computer literate
Planner & organiser
Active listener
Technical report writing
Qualifications and experience:
The successful candidate for this Quality Assurance Support Engineer role will have the following skills and qualifications:
Engineering degree or equivalent in quality / manufacturing / engineering and/or experience in quality assurance/engineering
Proven track record in compliance & continuous improvement projects
Basic PC skills.
Ability to interpret engineering drawings/specifications.
Familiarity in areas of various Inspection techniques.
Process excellence green belt/black belt
Working knowledge of quality systems (FDA/ISO) within a regulated environment.
How to apply:
For more information or to apply for this Quality Assurance Support Engineer role please contact Hannah Milward on 0114 283 9956 or email hmilward@ckscience.co.uk. Please quote reference SH23883 in all correspondence.
Hannah Milwardat CK Science is currently recruiting for a Quality Assurance Support Engineer to join a large multinational organisation involved in the treatment of musculoskeletal systems with products that include joint implants, trauma devices and biologic products. This will be on a contract basis for approximately 6 months at their site in West Yorkshire.
Job role:
The purpose of this Quality Assurance Support Engineer job is to provide quality engineering, process excellence support in a defined business unit / value stream environment for in-process, finished product, first articles and new product introduction.
Responsibilities:
As a Quality Assurance Support Engineer you will:
Actively support all Compliance Initiatives with the Value Stream and Plant
Actively support all defined Value Stream and Plant goals and objectives.
Identify projects to resolve scrap, reprocessing and special causes that have a negative impact on Value Stream and Plant Goals and Objectives.
Compile Quality Process Specifications for new/transferred products/processes
Be responsible for the introduction and correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new products. Quality process specifications to be compiled for on site production and purchased for resale goods (Goods In Check procedures)
Reviews product designs, test protocols and co-develop critical characteristics/tolerances for initial testing and validations and subsequent routine manufacturing controls.
Assist and where appropriate lead in the compilation and execution of validation protocols for new product/processes and software.
Ensure correct implementation as per standard validation procedures.
Re-validate as required due to engineering change, deviation analysis or upgrade in systems and materiel.
Manage QA related change control for specific projects as directed
Participates in process evaluations (e.g. FMEAs).
Devises and implements methods and procedure for inspecting, testing and evaluating plans for subsequent routine production.
Support Quality System activities within manufacturing cells such as Internal Audits, complaint investigations, close call and corrective action investigations.
Perform/document dimensional/visual inspections and non conformance and deviations as required
Manage a variable workload to meet operational requirements.
Ensure that all Health, Safety and Environmental requirements are fulfilled.
Qualifications and experience required:
The successful candidate for this Quality Assurance Support Engineer job must have an engineering degree or equivalent in quality, manufacturing, engineering and/or experience in quality assurance/engineering. They must also have:
Proven track record in Compliance & Continuous improvement projects
Basic PC Skills.
Ability to interpret engineering drawings/specifications.
Familiarity in areas of various Inspection Techniques.
Process Excellence Green Belt/Black Belt
Working knowledge of Quality Systems (FDA/ISO) within a regulated environment
For more information or to apply for this Quality Assurance Support Engineer role please contact Hannah Milward at CK Science on 0114 283 9956 or email hmilward@ckscience.co.uk. Please quote reference SH23883 in all correspondence.
The Yorkshire Post has reported that the medical devices company Tissue Regenix has asked for a new dedicated science park in Leeds
Mr Antony Odell the managing director of Tissue Regenix said it and other science firms need a dedicated science park, where they can grow and develop as a cluster, to retain skills and wealth in Yorkshire.
The company recently raised £25m to commercialise its innovative technology. Currently they are outgrowing its space at York Science Park. Mr Odell also said “We are looking at premises in York and Leeds. There’s not a dedicated bio park in Leeds”
Leeds City Council said it has narrowed down five possible sites to develop a healthcare science park. The sites include Leeds Valley Park, Logic Leeds, Thorpe Park, Hawks Park and Thorp Arch Estate near Wetherby.
Andrew Bolton at CK Science is currently looking for a Medical Device Auditor to join a world leading auditing & certification consultancy, which provides specialist services to the medical device & related technologyindustries. This role will initially be based between their sites in Hampshire & Germany during the training period, with the option to be field based thereafter.
Responsibilities:
As a Medical Device Auditor, you will be involved in:
Planning & conducting audits (ISO, IVD, MDD, FDA, MRA, CE Marking) of customer’s active medical devices, facilities & quality management systems (QMS)
Testing of active medical devices in line with relevant electrical standards
Reviewing & approval of technical file / design dossiers, significant change notifications and other technical documentation.
Within this role, you will be required to travel to customer sites within the UK, Europe, USA & Asia.
Qualifications and skills:
To be considered for this Medical Device Auditor role, you will have the following:
Degree in electrical engineering, physics or a related discipline (or equivalent)
Working knowledge of quality systems relating to medical devices (CE Marking, ISO 13485:2003 & ISO 9001:2008
Demonstrated experience involved in audits (internal or external).
Knowledge of another European language and/or experience as an Auditor in Medical Devices would be advantageous, but it is not essential.
Benefits:
This Medical Device Auditor role is an outstanding opportunity to join a leading auditing & certification consultancy for the medical device industries. In return they offer a competitive salary & excellent benefits.
For more information or to apply for this Medical Device Auditor role please contact Andrew Bolton on 01438 723 500 or email abolton@ckscience.co.uk. Please quote reference ST23810 in all correspondence.
Naynesh Mistry has been with CK Science since August 2012 and is based in the Chesterfield office. He is responsible for permanent scientific recruitment in the following industries in the Midlands area:
Hannah Milward is looking for an experienced medical devices Product Evaluation Engineer to join a international medical devices organisation with a reputation for developing innovative and cutting edge products within this dynamic industry.
Responsibilities:
The primary objective of this Process Evaluation Engineer role is to improve the success of New Product Developments (NPD). The PE Engineer has responsibility for the generation of documentation and conduct of testing to support PE activities within NPD projects. The PE Engineer shall ensure that valid and robust data is obtained and documented during execution of validation and verification activities.
Key responsibilities of this role are:
Produce design verification protocols, reports and perform the product testing where necessary.
Design, develop and validate appropriate test methods
Participate in NPD phase reviews, presenting the results and progress summaries of activities for which they are responsible.
Ensure clinical model definition – translation of the intended clinical usage of a device into a definition in quantifiable engineering terms of the operational and environmental conditions that the device must with stand
Participate in risk management and FMEA exercises.
Review and contribute to the necessary design input documents
Interface with design, marketing, clinical, manufacturing and quality teams to ensure the PE function is fully integrated within the NPD team
Conduct programmes for extended life / reliability testing of new products
Analyse and report on Customer Enquiries
All other essential related duties as required
Qualifications & skills required:
To be considered for this Product Evaluation Engineer role you will possess the following:
Degree or equivalent calibre in science, engineering or technology discipline with demonstrable relevant experience, preferably within the medical device industry
Experience of quality or product test fields
Good organisational skills
Attention to detail
Concern for quality and standards
Customer focus
How to apply:
For more information or to apply for this Process Evaluation Engineer role please contact Hannah Milward at CK Science on 0114 2839956 or hmilward@ckcience.co.uk. Please quote reference SH22946 in all correspondence.
Reena Dhana at CK Science is currently looking for a Principal Mechanical Engineer and a Mechanical Engineer to join a Medical Devices company based in Cambridge.
For more information, please contact Reena Dhana at CK Science on 01438 723 500 or email rdhana@ckscience.co.uk.
Our client a global pharmaceutical company are currently looking for an experienced Mechanical Design Engineer who can lead the design and development of pharmaceutical devices to join their team in Hertfordshire.
Responsibilities and Skills:
The ideal candidate will be a senior Mechanical Design Engineer, with experience of medical device design, mechanisms and the detail design of plastic injection moulded components for high-speed assembly.
The candidate will be able to create innovative design solutions and develop these into robust products using CAD, FEA and tolerance analysis software.
The level of CAD competency will be to an advanced surfacing level with a good understanding of top down design.
It will be necessary to have good communication skills in order to both present and review designs with suppliers, customers and team members.
Qualifications:
The ideal candidate for the Mechanical Design Engineer role will possess a HNC in Mechanical Engineering (or equivalent) with experience of Pro/Engineer Wildfire (essential, preferably version 4 or higher), Ansys Workbench v12 (desirablel) and CETOL 6d v8.1 (preferable but not essential). This is a contract position for 12 months.
Apply now:
For more information or to apply now for this Mechanical Design Engineer position. Please contact Julie Marshall on 01438 723 500 or jmarshall@ckscience.co.uk. Please quote reference ST22113 in all correspondence.
Our client is a world leading Medical Device Organisation who is involved in the development of various medical devices & diagnostic products. They are currently looking for two QA Officers at different levels to join their Quality & Regulatory Team based from their site in Oxfordshire.
Responsibilities:
As a QA Officer (Medical Devices) you will be responsible for:
Assisting with the development of process & procedures on site
Review of quality documentation (ISO 13485) and device history records (DHRs) including approval/rejection of DHRs prior to release to sales & distribution
Provide support during internal and customer audits when required.
The senior of the two roles will also lead members of the quality team in absence of the team leader.
This is an outstanding opportunity to work with a leading name in the Medical Device industry. In return they offer an attractive salary and excellent benefits.
Qualification and Experience:
To be considered for this role, you will have demonstrated experience gained in a quality function including knowledge of ISO 13485 gained within the medical device, diagnostic or a related technology sector.
Apply now:
For more information or to apply for this QA Officer – Medical devices position. Please contact Andrew Bolton on 01438 723 500 or abolton@ckscience.co.uk. Please quote reference ST22052 in all correspondence.
Carrie Ann Bell is one of the recent additions to the ever expanding CK Science team and is based in our Durham office. Carrie Ann specialises in recruitment for the Pharmaceutical, Biotechnology, Medical Devices and Diagnostics industries.
Find out more about Carrie Ann by watching this short video:
