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Job Details
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QA Manager



Business Type: Medical Communications Agency
Job Type: Quality Assurance - Control
Job Level: Experienced (non manager)
Position: Full Time
Salary: £competitive
Location: Scotland (Central)
Reference: 889078
Closing Date: 16/09/19
Job Details:

QA Manager - Medical Devices - Edinburgh / UK remote - £competitive

The Company

Our client is a start up medical devices company specialising in wearable home and hospital care products. They are looking for an experienced Quality Manager to join their team in Edinburgh or on a remote working basis in the UK. This is a rare opportunity and exciting time to join a unique and growing business within the medical devices market!

The Role

  • Act as a leader of global quality, influencing a "Quality By Default" culture and owning the Quality Management System (QMS)
  • Development and maintenance of the QMS that meets Regulatory and business expectations for physical medical devices and software as a medical device
  • Augment and improve the QMS to reflect both best practices and internal development process
  • Maintain the organisational knowledge of laws and regulations, provide oversight of current and evolving regulatory requirements to ensure the QMS remains current
  • Be an active participant in the product development lifecycle, advising on quality management requirements and ensuring these developments are supported by the QMS
  • Establish and improve product lifecycle processes to ensure quality is maintained at the heart of our development strategy
  • Perform internal audits and assessments as applicable. Ensure readiness for and hosting Notified Body audits
  • Maintaining documentation such as design dossiers, technical files and Declarations of Conformity
  • Evaluating and monitoring sub-contractor compliance and maintaining Technical Agreements as appropriate

You

  • Past experience of working in a start-up culture is preferred.
  • Proven experience of managing Quality Assurance in the Medical Device Industry with ownership of a quality management system is a must
  • Recent experience with complex electronic, electro-mechanical and a software as a medical device
  • Demonstrable experience of conducting quality reviews, internal quality audits and reporting on system performance. being Certified Auditor will be considered a significant plus
  • Strong and practical knowledge of ISO 13485, FDA CFR 820, MDSAP, MDD and MDR as well as emerging standards and regulations
  • Experienced in writing/submitting 510k''s and CE Technical Files.
  • A BSC degree or equivalent in a Life Sciences field would be ideal
  • It is important you can pragmatically balance quality with a fast-paced schedule
  • You are a good team player, ready to help, debate, compromise and work together
  • You are comfortable working, prototyping and delivering incrementally, adapting based on customer needs and technical difficulties, always with the user in mind

What should you do next?

This QA Manager role is one not to be missed; it encompasses the opportunity to work with market leading medical device products in a growing business! To discuss further, please submit your current CV.

Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.

Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.



Posted: 19/08/2019 | NPJ Ref: 240464
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