Senior Quality Engineer (Design Control)

SEC Recruitment
£45180.50 - £49698.55 per annum
Closing date
1 Oct 2020

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Quality, QA / QC
Full Time
Contract Type
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Senior QA Engineer

A great opportunity with a market-leading medical diagnostics organisation has arisen, with an opportunity to play a key role in the company's R&D QA Division where you will be responsible for design change and innovation projects. Initially this is a project until the end of 2020, with a strong likelihood to extend throughout 2021.

Salary & Benefits:

€55k pro rata. Full details on request (opportunity open to

Role and responsibilities:

*Reviewal of design projects throughout the Design Control process for compliance and ensuring of compliant closure of Design History Files (DHFs).
*Support the Design Control Process, including design change.
*Reviewal and approval of validation protocols (equipment validation, utilities, process validation, cleaning validation, test method validation and software) and final validation reports ensuring compliance to all SOPs and WIs
*Updating of Design Control and R&D procedures/systems
*conduct internal audits, ensuring compliance of R&D and technical areas (System Integration, Packaging Development and Customer Support) with ISO13485 and FDA quality requirements.
*Risk Management specialisation
*Complete reports on post market surveillance

Requires skills and qualifications:

*Scientific Degree with 2 years' industry experience (Doctorate level), 3 years' industry experience (Master's level) or 5 years' industry experience (Bachelor's level)
*Experience in a highly regulated (FDA desirable) healthcare or related environment
*Experience in IVDDs, Design Controls and/or Risk Management

To apply for this position and put yourself under immediate consideration, send your CV to or call +44 (0) 207 255 6650

It’s easy to say, ‘we’re different’ as a recruitment business, which is why at SEC we like to show our candidates and clients that we are through our actions and our delivery. We are a life sciences and IT specialist recruitment agency that lives by four core values of trust, honesty, integrity and commitment. To us these are more than just words on a website. These are ways in which we want you to feel every time you talk to us.

Our aim is to be the European life sciences partner of first choice to everybody who works with us. We speak over 20 different languages collectively and can support you with what you need.

So, talk to us. Call us, browse our jobs, see how we are helping change both people and employers’ lives.

Contact Us
  • 3rd Floor,
  • 13-15 Moorgate
  • EC2R 6AD
  • GB
  • 00 44 (0) 207 255 6600
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