Liz Streeter

quality assurance and regulatory affairs expert
Quality Assurance
Regulatory Affairs
ISO 13485
CE Technical Files
Medical Device Regulations
LSAS

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An expert in quality assurance and regulatory affairs, Liz Streeter provides clients with quality management systems (QMS) that seamlessly integrate into their business. With over 30 years of experience in the industry, Liz has worked in all areas of manufacturing, including 22 years of working with medical devices. Her main objective is to help clients meet industry standards through effective implementation of quality systems that are genuinely useful to the company.

Liz began her career in the NHS, and quickly moved into quality assurance for both medical devices and industrial manufacturers before managing QA systems and regulatory affairs for Welland Medical for 12 years. Having developed excellent contacts in several notified bodies (NBs), she will act as an effective intermediary between client and NB. Her extensive experience has given her an advanced understanding of meeting ISO 13485, 9001 and other industry required standards, and has made her highly proficient in fitting QA systems into companies’ everyday operations. Indeed, she works in the belief that QA should actively contribute to the smooth functioning of a company and should never be in place simply to meet requirements.

Liz has extensive experience with European Medical Device Regulations and the writing of CE Technical files. This is a further service that Liz provides, having written many of these for clients, successfully achieving CE certification. She is very proactive in keeping up to date with potential and real changes in standards, directives, regulations, MEDDEVs and general industry comments and will always analyse what effect these may have on her client base.

Liz in an experienced trainer who delivers bespoke training for all quality assurance and regulatory affairs requirements and subjects.  She offers sessions individually or on an ongoing basis, which can be used as just enough to satisfy the standard, or as a method of assisting employees in their lasting career progression.

Never one to simply point out problems, Liz consistently finds innovative solutions for her clients by working with them at all stages of the manufacturing process. She is comfortable getting involved on the factory floor, performing as much or as little as the client requires to reach regulatory standards. An advocate of practising what she advises, Liz provides ongoing quality assurance and regulatory affairs support once a system is installed – something of particular value to new start-ups and small businesses – and she even runs the systems for one of her regular clients.

Labour Standards Assurance is something currently required for a number of NHS Supply Chain contracts and Liz has become skilled in assisting those medical device manufacturing clients who need to perform to this more recently set up standard.

Email: lizstreeter@openwater.uk.com

Phone: 0044 (0) 7778 317806

Connect with Liz on LinkedIn.