Andrew Boltonat CK Science is currently looking for a Chief Operating Officer to join an international medical device organisation, specialising in the development & manufacturing of industry changing molecular diagnostic technology to be based from their site in Wiltshire.
Responsibilities:
As the Chief Operating Officer (COO), you will be responsible for planning, developing & implementing strategies across operational management & development including management of internal operations encompassing commercial manufacturers, supply chain, logistics, materials management & technical support to customers.
Your duties will include:
A key member of the Executive Leadership Team liaising with other Directors & Managers, coupled with leading, managing & developing Operations Team.
Lead, drive and manage the development and evaluation of the Company operational strategy and performance.
Establish and maintain appropriate systems for measuring necessary aspects of operational management and development.
Monitor, measure and report on operational issues, opportunities, development plans and achievements within agreed formats and timescales.
Maintain awareness & knowledge of operational best practice to achieve company goals.
Represent the company at meetings with external parties, customers & at industry events / conferences.
This is an outstanding opportunity to join a growing Diagnostic organisation, which in return offers a negotiable salary & benefits package.
Qualifications and Skills:
To be considered for this Chief Operating Officer role, the successful candidate will have a Degree / PhD in a Life Science or Engineering discipline (or equivalent) and:
Proven track record of growing R&D / Medical Device companies.
Working knowledge of the Medical Device and/or Diagnostic industries.
For more information or to apply for this Chief Operating Officer role please contact Andrew Bolton on 01438 723 500 or email abolton@ckscience.co.uk. Please quote reference ST23651 in all correspondence.
Graeme Pallas at CK Science is currently recruiting for a Regulatory Affairs Officer to join a Medical Devices company based in the North East of England. This is a six month contract position.
Responsibilities:
Prepare regulatory submissions for countries that implement marketing regulations including US, Canada, Japan and China.
Manage creation and development of technical files.
Manage and maintain medical device registrations.
Provide regulatory input in to product development projects.
The ideal candidate:
To be considered for this Regulatory Affairs Officer role, you will have demonstrable experience of Quality Management Systems such as ISO13485 and ISO9001. Ideally, you will have regulatory submission experience of 510(k) and Technical files for in-vitro medical devices.
How to apply:
For more information or to apply for this Regulatory Affairs Officer position, please contact Graeme Pallas on 0191 384 8905 or email gpallas@ckscience.co.uk. Please refer to reference 22613 in all correspondence.
CK Science is currently helping a world leading Medical Device Consultancy to recruit a Project Engineer to join their state-of-the-art facilities in Cambridgeshire. This fantastic company develops a range of technologies for their customers in the Pharmaceutical, Biotechnology and Medical Devices industries.
Responsibilities:
As a Project Engineer, your main responsibilities will include leading multi-disciplinary teams on projects within the drug delivery, diagnostic and other medical technology applications. Further duties of this role will include:
Working closely with customers to identify and design technical product or system solutions and in turn producing proposals to meet their requirements
Leading design engineering including hands on use of 3D CAD to produce designs of components, systems or products
Working closely with 3rd party suppliers for transfer of project to manufacture as well as managing technical documentation relating to the project.
Person specification:
To be considered for this Project Engineer role, you will have the following skills, qualifications and experience:
Degree / MSc / PhD in Mechanical Engineering (or equivalent)
Demonstrated experience of both project management and hands on engineering for technology applications including knowledge of manufacturing processes (one off design or volume)
Experience using 3D CAD (pref. Pro-E or Solid Works)
Specific experience in the medical device industry would be advantageous but it is not essential.
How to apply
For more information or to apply for this Project Engineer position, please contact Andrew Bolton at CK Science on 01438 723 500 or email abolton@ckscience.co.uk. Please quotereference ST22101 in all correspondence.
Our client, a Scottish diagnostics company require a Regulatory Affairs Manager on a temporary basis to cover maternity leave.
Reporting to the Quality Assurance/Regulatory Affairs Director you will be responsible for a small team ensuring company activities are in compliance with regulations applicable to the diagnostics industry.
To be considered for this Regulatory Affairs Manager position, you must have the following skills and experience:
Have experience of working within or in close interaction with the RA team in relation to regulatory submissions or verification activities.
Be knowledgeable about the requirements of at least one of the following areas, IVD Directive, FDA 510k submissions, cGMP requirements as they impact on RA.
Have experience in interacting with external partners and regulatory agencies including the FDA.
Have the ability to build key relationships within the senior management team to promote and direct RA within the organisation.
Have supervisory experience.
Educated to degree level in a life science subject or have demonstrable experience in a regulatory affairs position.
How to apply
For more information or to apply for this Regulatory Affairs Manager position, please contact Graeme Pallas on 0191 384 8905 or email gpallas@ckscience.co.uk.
CK Science is looking for a Technologist to join a world leading Medical Device organisation based in Oxfordshire.
As Technologist you will join the company’s Quality and Regulatory team and will be involved in the development of various medical devices and diagnostics products.
This is an excellent opportunity to work for a leading name in Medical Device development and manufacturing. In return, they offer a competitive package combined with strong career prospects.
Responsibilities:
Working as a Technologist, you will be responsible for carrying out complete device and component testing on a wide range of medical devices & diagnostic equipment using techniques such as AQLs, Force Tests, Wet Tests and Spring Testing. As part of the quality team, you will also be required to complete relevant quality documentation (ISO 13485, GMP) following testing and support internal and customer audits when required.
Requirements:
To be considered for this role, you will have a qualification in a Scientific or Engineering discipline (or equivalent) and demonstrated experience in a device / component Testing or Quality role gained within the Medical Device, Diagnostic or a related technology industry.
How to apply
For more information or to apply for this Technologist position, please contact Andrew Bolton at CK Science on 01438 723 500 or email abolton@ckscience.co.uk. . Please quote reference ST22054 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.
Our client is a world renowned Medical Device organisation who develop innovative & industry leading devices. They are currently looking for a Quality Engineer to join their QA & RA Division based from their site in Hampshire.
Responsibilities:
Working as a Quality Engineer, you will be responsible for working across the Production, Development & Quality internal teams as well as external suppliers.
Your duties will include:
Developing, creating and maintaining regulatory & quality system (ISO 13485, ISO 9001, Medical Device Directives) documentation
Developing & carrying out equipment & process validation
Aiding with transfer of new products to manufacturing
Carrying out non-conformance & root cause analysis and implementing corrective actions as well as assisting with internal & external (customer & supplier) audits
In addition to your duties in the Medical Device side, you will also be involved in supporting a small pharmaceutical division as and when required.
This is an outstanding opportunity to join a blue chip Medical Device organisation, which in return offers an attractive salary, an excellent bonus scheme and benefits package.
Qualification and Experience:
To be considered for this role, you will have a demonstrated background in a Quality Engineer or related Regulatory Engineering function gained within the Medical Device, Pharmaceutical, Biotechnology or a relevant industry.
Apply now:
For more information or to apply for this Quality Engineer position, please contact Andrew Bolton on 01438 723 500 or abolton@ckscience.co.uk. Please quote reference ST21952 in all correspondence.
CK Science are currently recruiting for a Senior Technologist to join a Pharmaceutical/Medical Device company based in Oxfordshire.
Based within the New Products division, you will provide technical support to New Product introduction (NPI), in particular supporting the characterisation, validation and verification of new products, procedures, materials and tests.
You will take ownership of projects associated with NPI and will oversee all project management, Quality, Validation and organisational aspects required.
The process area and the processes themselves are complicated and as such we require someone who is a quick learner, that is organised and that is self driven. You will work well as part of a team as well as autonomously and it is essential that you have the ability to drive long term projects. It is essential that you have excellent communication skills both written and verbal as you will need to complete technical documentation and present data to all levels within the organisation.
Requirements:
The ideal candidate will hold a scientific or engineering degree (or equivalent) and will have gained experience within the Pharmaceutical or Medical Device industries. They will have knowledge of manufacturing or production and will be able to work under pressure and to tight deadlines. They will also have an understanding of the principles behind Lean Six Sigma and continuous improvement together with a good understanding of cGMP and quality systems, particularly in areas of the Design Control and Validation.
Apply Now
For more information or to apply for this Senior Technologist job, please contact Jason Johal at CK Science on 01438 723 500 or email jjohal@ckscience.co.uk. Please quote reference ST21849 in all correspondence.
Our client, an industry leading Medical Device Diagnostic organisation, are currently looking for a Senior Chemist to join their Research & Development Team based from their site in Cambridgeshire.
Responsibilities:
As a Senior Chemist, you will be responsible for project management of a multi-disciplinary project team involved in research into novel glucose biosensor technology for use in various diagnostic and point-of-care diagnostic applications.
Your duties will be split between people management of a team of Scientists & Engineers and hands on aspects including conceptualisation & design of the optical grating based sensors; conducting studies to devise methods of manufacture at lab scale as well as development of prototypes and test rigs in order to carry out verification, validation and test of sensor designs and method of manufacture.
This is an outstanding opportunity to join an innovative and industry leading Medical Device Diagnostic organisation, which are at the forefront of development in novel biosensor technology.
Qualifications and Experience:
To be considered for this Senior Chemist role, you will have a BSc / MSc / PhD in a Chemistry, Materials or Physical Science discipline (or equivalent) and proven practical experience in a product development function of medical device technology including demonstrated project management / people supervisory experience and working knowledge of polymer coatings & materials used in optical technology. Specific knowledge of diagnostic medical device / biosensor technology would be highly advantageous, but it is not essential.
Apply Now
For more information or to apply for this Senior Chemist position, please contact Andrew Bolton at CK Science on 01438 723 500 or email abolton@ckscience.co.uk. Please quote reference ST21767 in all correspondence.
Our client is a leading Medical Devices Organisation. They are currently searching for a Mechanical Engineer to join there Multidisciplinary Research and Development team based in the Hertfordshire/Cambridgeshire region.
Working as a Mechanical Engineer you will be working within a multidisciplinary team of Scientists and Engineers.
Responsibilities:
As a Mechanical Engineer, you will be involved in working on and leading demanding technology and product development projects in sensor technology, optical electronics and/or device physics for markets ranging from healthcare to consumer products.
Person Specification:
To be considered for this Mechanical Engineer role you will have a BSc in Mechanical Engineering or related discipline (or equivalent). Excellent knowledge of fluidics, structures, materials and/or thermodynamics. Previous experience in medical device development would be advantageous but not essential. Experience with MATLAB and/or MATHCAD would be ideal. Project management experience would also be ideal.
Apply Now
For more information or to apply for this Mechanical Engineer position, please contact Reena Dhana at CK Science on 01438 723 500 or email rdhana@ckscience.co.uk. Entitlement to work in the EEA is essential. Please quote reference ST21456 in all correspondence.
