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Quality Specialist

£competitive | Buckinghamshire |  Quality Assurance and Supply Chain, QA |  Permanent  | Ref:889587

The Role

Quality Specialist - Medical Devices - Buckinghamshire - £Competitive

The Company

Our client is an established medical devices company that specialise in developing products for stoma, urology and wound care. For this role they are offering:
  • Competitive salary, private health care, life assurance and free onsite parking
  • Friendly team and company culture
  • High responsibility and travel opportunities

The Role

Our client is looking for a Quality Specialist with a background in medical devices to join their team in their Buckinghamshire office.
  • To review, maintain and develop the company QMS system to ensure compliance with relevant standards (ISO 9001, ISO 14001 and working with the Regulatory specialist on ISO13485) and applicable regulations.
  • To work closely with, and provide support for, the Regulatory Management Specialist
  • Drive QMS improvement in usability, visibility and engagement
  • Work with the Quality Associate and relevant departments to monitor and improve the complaints processes related to service, distribution and dispensing of product
  • Assist the business in developing SOPs to maintain compliance. Review existing SOPs and approve as necessary, offering input to streamline processes where possible
  • Ensure Good Distribution Practice is followed in relation to relevant processes. Work with the Responsible Person to monitor and ensure compliance.
  • Provide training on quality aspects and standards to all levels of the business as required
  • To co-lead on change control with the Regulatory Specialist
  • To participate in continuous improvement, corrective actions and business risk minimisation.
  • Develop the internal audit plan to ensure compliance and chair internal audit meetings as required
  • Plan and conduct internal audits and follow up in accordance with the QMS.
  • Undertake external audits on suppliers as required
  • Host audits as required by external regulatory bodies/customers.
  • Promote quality activities to achieve the standards of excellence as set out in the company's quality and environmental policies.
You
  • Educated to degree level in a scientific, engineering or relevant discipline
  • Proven quality experience from medical devices or pharmaceutical/ healthcare/cosmetics fields
  • Expert knowledge of ISO9001, ISO 14971 and experience of internal auditing
  • Experience interpreting, implementing and communicating changes in Regulatory policy and Quality standards
  • Excellent written communication and presentation skills

What should you do next?

This Quality Specialist role is one not to be missed; it encompasses the opportunity to be an integral and important part of a growing team! 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.

Consultant

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Nadya Libecans

Which team and area do you work/specialise in?

I work on the Drug Development team specialising in Quality (QA) and Supply Chain roles within the pharmaceutical, medical devices and consumer healthcare markets.

What are some of the typical roles you cover?

I cover all levels from Administration to Director level within QA, QC, Supply Chain, Procurement and Logistics.

What are the hot issues in your sector currently?

For both Quality and Supply Chain, Brexit is a huge topic at the moment. Clients and candidates I work with have been working extensively to organise contingency strategies to minimise the effects to cost of manufacture and speed of product delivery.

Who is your biggest idol / inspiration and why?

I have two. Firstly, my mum who is the strongest role model I have in my life. She has taught me the importance of independence, security and resilience. Secondly, I’d have to say Catherine Ryan who has proved that you can really have it all and a sense of humour.

What is your greatest fear?

Being unsafe – the thought of not being able to get out of a situation where you feel you might die. Safe to say, I will not be climbing Snowdon again!

How would your friends describe you in three words?

Independent, nurturing and fun

You’re stranded on a desert island – what one thing could you not live without?

A Swiss army knife so I can open coconuts, hunt and make a shelter

What’s makes you #DistinctlyDifferent?

I believe knowledge is power and I strive to learn as much about people and the industry as possible to build lasting relationships and produce the best results for candidates and clients. 

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