QA Officer – (Medical Device) Oxfordshire

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.

                                                   Click here to apply on line:

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Senior Technologist Job – Oxfordshire, UK

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.

Click here to apply online now!

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Contract Quality Engineer Job (Medical Devices) – South Wales

Our client is a world leader in the production of medical visualisation and energy systems for the medical devices industry based in South Wales. The company are currently looking to recruit a contract Quality Engineer to support implementation of Quality Engineering Activities in product design, manufacture and vendor quality assurance in accordance with Company procedures and regulatory requirements.

 

Essential Duties and Responsibilities:

As a Quality Engineer, you will have the following duties and responsibilities: 

  • Support operations or as a new design project member, providing directed quality engineering and regulatory expertise in support of design projects. Ensuring solutions are compliant, in the most efficient manner with ISO 13485, FDA 21, CFR Part 820, MDD 93-42-EEC, and their associated applicable consensus standards (IEC60601 series, ISO 11607, ISO 10993).
  • Take a role in ensuring approximate risk management tools such as risk analysis, pFMEA and dFMEA are performed adequately.
  • Review and approval of quality related documentation via ORACLE PLM or other systems including software, mechanical and electronic technology aspects.
  • Assist in the development of appropriate verification and validation strategies including test method validationfor products, processes and components.
  • Generation of process validation plans, review and approval of validation documentation.
  • Where required liaison with vendors including auditing and co-ordination of component qualification activities.
  • Where required support of CSV activity.
  • Provide ad hoc Quality Engineering support in other areas such as; other projects, operations problem analysis, process analysis and process and vendor improvements.
  • All other essential duties as directed.
  • To adhere to the “Rules and Regulations’ of the company as laid out in the Staff Handbook.

 

Education:

The successful candidate for this Quality Engineer position will have the following educational qualifications:

  • HND or equivalent calibre in engineering, science or technology discipline.
  • Proven experience in a quality related field.
  • Preferably experience of a Medical Device environment or similar regulated industry.
  • Exposure to quick evolving environments with cross functional team working.

 

Essential Knowledge, Skills and Abilities:

  • Ability to interpret technical drawings and specifications.
  • Basic understanding design and manufacturing processes.
  • Strong metrology skills and understanding of inspection techniques and schemes.
  • Awareness of FMEA or other risk analysis techniques.
  • Experience of use of ORACLE PLM, MS Ecxel,MS Word and Minitab or equivalent.
  • Ability to review technical documentation and drawings in a consistent, constructive and timely manner.
  • Appreciation of vendor quality system auditing skills and vendor development ability.
  • Application of a wide range of inferential statistical techniques.
  • Excellent report writing and presentation skills.
  • Appreciation of requirements of working in a regulatory controlled environment.

 

Apply Now

For more information or to apply for this Quality Engineer job please contact Russell Oakley at CK Science on 0114 283 9956 or email roakley@ckscience.co.uk. Please quote reference SH20964 in all correspondence.

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