Quality Officer

Search Consultancy

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

United Kingdom,--Newcastle upon Tyne,Newcastle upon Tyne,

Key Skills :

QA, Quality Risk Management, Quality Systems, Supplier Management, Audits, CAPA, Quality Assurance,

Salary :


Date Posted :

11 May, 2017

Company Name :

Search Consultancy

Location1 :

Newcastle upon Tyne

Job Category :

Quality Assurance Jobs

Experience :


Job Type:


Travel Amount:



Quality Assurance / QA Officer - Medical Device

My client is an exciting medical devices company that are leading the way in developing simple to use devices. They currently have requirements for a Quality Assurance / QA Officer to join the team. You will be responsible for ensuring regulatory compliance of the Quality Management System

This position will suit somebody who is looking to work in a fast paced, cross functional group environment, with a willingness to be hands-on across a wide area of responsibilities. Also someone who wants to take on new responsibilities and challenges long term.

The Role:

* Support management and leadership of the Quality Technical section.
* Ensure regulatory compliance as the company enters product development and commercialisation phases. This will include working toward ISO 13485:2016 certification and compliance with BS EN ISO 14971:2012.
* To develop QMS documentation to ensure it evolves in accordance with regulatory and business requirements.
* Support quality systems to ensure the site remains compliant with current requirements.
* Ensure Technical/Design History Files are effectively maintained and comply with current requirements
* Maintenance of electronic Quality Management System, Q-Pulse including monitoring and progression of CAPA and audit actions.
* Prepare and audit schedule and conduct audits in accordance with ISO 13485:2016, ISO 14971:2012, and internal company procedures.
* The role will also involve supporting validation activities and providing general compliance support to the site.

The Candidate:

* Candidates will have a degree or equivalent qualification in a science based subject.
* Previous experience in a Quality Assurance role will be highly desirable.
* Experience in the Medical Device industry, working to ISO 13485:2003 standards would be desirable.
* Experience of using electronic Quality Management Systems such as Q-Pulse
* Previous experience in internal and external auditing, validation and operational support will be desirable.
* Ability to identify opportunities for process and operational improvements and implement appropriate changes to deliver these benefits.
* Has a passion for quality excellence.

Key Words: QA, Quality Risk Management, Quality Systems, Supplier Management, Audits, CAPA, Quality Assurance, Technical/Design History Files, 93/42/EEC, ISO 13485:2003

The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. Search Scientific, part of Search Consultancy is an Employment Business/Agency.

Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.

Company Name:

Search Consultancy


Campbell House,215 West Campbell Street


Staffing Firms


United Kingdom






100 - 499





Phone No. :


For more information,visit www.search.co.uk.

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