Quality System / Design Control Specialist

Job Ref: J32049
Sector: Science
Sub-sector: Biotech/Life Sciences
Job Type: Permanent
Date Added: 24 May 2019
  • Birmingham, West Midlands, England, UK Birmingham West Midlands UK B15 1QT
  • Competitive
  • Eleanor Gorton
  • 0121 728 8455
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Quality System / Design Control Specialist

Location - Birmingham

Competitive Salary

My client is looking for someone who can cover New Product Development (NPD), Quality Assurance (QA) and change control system on a daily basis.

The role:

* Ensuring that the NPD and Change Control systems are followed in line with company requirements and external regulations (ISO9001/13485, FDA QSRs

* Ensuring all verification, validation and all other requirements are in place before approving internal release of new products for sale

* Reviewing, approving and managing the progression to completion of Change Orders.

* Providing QA support with the Risk Management areas of the business.

* Working within the QA team to ensure the company maintains compliance to External and Internal Quality System Requirements.

* Aiding in periodic internal and external audits as requested.

Desired traits / skills:

Degree or equivalent in Biological Sciences or similar

Experience of ISO14971 - Risk

The ideal candidate needs to be able to make sure everyone else is co-operating within their line of work.

The client is looking for an individual who displays confidence, positive attitude, excellent communication skills, great attention to detail, leadership skills, and the ability to understand the company's products and processing.

Due to the role being within a QA environment, it will also be desirable if you have the confidence to stand up and by what you say when making a QA decision. Previous leadership experience is desirable, however not essential as training will be required


* A levels or equivalent in Science

* Working knowledge of FDA Part 820, 806 and 803 and ISO13485.

* Experience of working within a QA or RA environment within an IVD or medical device company

* Experience of Non -Conforming Product and Corrective Action systems.

* Excellent communication skills (both written and verbal)

* An excellent eye for detail

* The ability to follow processes

* To have an Inquisitive mind

* To be flexible to the needs of the business.

If you are interested please contact Ellie on 0121 728 8458 or Ellie.Gorton@srg.co.uk

23/06/2019 09:29:15