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QA/RA MANAGER/STABLE COMPANY/SOLIHULL

Employer
NonStop Consulting
Location
Solihull
Salary
Negotiable
Closing date
Mar 21, 2017

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Sector
Pharmaceutical, Business Development
Contract Type
Employee
Hours
Full Time
Organization Type
Clinical Practice

Job Details

QA/ RA MANAGER/STABLE COMPANY/ SOLIHULL WEST MIDLANDS

The company I am working for is dedicated to offering products that enable patients anywhere who are in need of blood and or an organ to receive the right match that is safe, accessible and affordable.

You will be having the chance to work with really innovative products within blood transfusion and transplant which will make you an expert in this really niche area.

Being a family owned company makes this company really stable, you will have the security of a long term project where you can learn important skills and at the same time not thinking of the upside and downs of the market.

We are looking for a QA/RA Manager who will join our amazing team.

RESPONSABILITIES :

  • Manage regulatory and quality projects in context with the EU /WW Quality Management System and applicable regulatory requirements.
  • Develop, implement, and manage local and international RA / QA system(s) in respect to the EU / WW Quality System and applicable standards like ISO 13485, ISO 9001 and the In-vitro Diagnostic Regulation.
  • Monitor local (UK) quality and regulatory requirements and develop strategies to maintain compliance.
  • Support international regulatory activities, such as product registrations activities for Immucor products in global markets.
  • Support training and education programs in cooperation with the Training Department.
  • Act as an enterprise wide representative of the RA/QA department. Develop and support a positive liaison between the company and regulatory agencies in the area of responsibility.
  • Support a positive liaison between the company and notified bodies.
  • Support documentation regarding regulatory approvals on international level.
  • Monitor effectiveness and implementing all the actions needed to ensure processes compliant to the Quality Management System.
  • Provide support to vigilance processes and to registration processes.
  • Support and conduct internal and external audits.

REQUIREMENTS:

  • strong experience within ISO 13485, ISO 9001
  • ideally someone from the IVD market
  • audit experience
  • experience in obtaining the CE mark - submissions etc

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

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