Stephanie Rowden

Stephanie Rowden Email and Phone Number

Medical Device Consultant | Co-Director of Fittsisters | Marketing | Chef @ LaproSurge Ltd
watford, hertfordshire, united kingdom
Stephanie Rowden's Location
Lightwater, England, United Kingdom, United Kingdom
About Stephanie Rowden

Please see below for a summary on my 2 Limited Companies, which I am equally passionate about.....•MEDICAL DEVICE CONSULTANT•I am a global Quality Assurance & Regulatory Affairs specialist within the medical industry. Guiding clients to ISO, FDA & CE compliance. I am the director of my own company, European Devices & IVD associates Ltd. And work in partnership with Procorre, a global, professional service consultancy that represents medical device businesses. ***PLEASE CONTACT MY PROJECT MANAGER ON TQMUK@AOL.COM WITH ANY QA/RA ROLES***____________________________________________•FITTSISTERS•Fittsisters was created in 2014 by myself & my sister, Kelly-Louise, to give women not only health & fitness information/ education, but to give them a support network. We are both qualified personal trainer with extensive qualifications, I am also a qualified chef and we are both professional athletes with The WBFF. I won my pro title in 2014 on the world champion stage in Las Vegas, and we have both had many articles and features in prestigious publications such as Muscle & Fitness magazine. We are so passionate about helping women find balance, reach their fitness goals & feel it's so important to have a healthy mindset as well as a healthy body. @fitt_sistersWww.fittsisters.net

Stephanie Rowden's Current Company Details
LaproSurge Ltd

Laprosurge Ltd

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Medical Device Consultant | Co-Director of Fittsisters | Marketing | Chef
watford, hertfordshire, united kingdom
Website:
laprosurge.com
Employees:
6
Stephanie Rowden Work Experience Details
  • Entrepreneur
    Entrepreneur
    Entrepreneur Feb 2012 - Present
    International
    Fittsisters is a brand that was created by two WBFF Pro's, Kelly-Louise Rowden and Stephanie Jane Rowden, who also happen to be sisters. We created the brand during their first years of competing as they wanted to give people a safe place to learn about health and fitness, and also a place to support and motivation each other.As well as competing and modelling within the fitness industry we also offer:-Personal Training.-Online Coaching.-Nutrition.-Posing Workshops.-Business Opportunities.We expanded our business and moved into the clothing and beauty sector where we have created gym designs which are stylish but comfortable and makes our fellow, hard working Fittsisters stand out from the crowd.Our skincare and cosmetics business is focused around being safe and beneficial and all products are free from chemicals, gluten, animal testing and are vegan certified. We are looking for people who want to change their life and gain that freedom, time and money that they deserve with out business opportunity. We are just two sisters, who had a goal and a dream to motivate and inspire others and maybe change some lives along the way.www.fittsisters.netwww.kellylouiserowden.arbonne.com
  • Laprosurge Ltd
    Qa/Ra Associate.
    Laprosurge Ltd Oct 2016 - Present
    Watford, United Kingdom
    Assisting the client’s QA/RA ‘expert’ to update their QMS to ISO 13485:2016 (i.e. new level 1 Quality Manual and updated level 2 SOPs), and to correct deficiencies identified during an SGS audit on-site (specifically x2 TF’s for OBL which needed corrections to sub-sections such as the Essential Requirements, Risk Management, Labelling etc., according to the ‘STED’ format guidance.
  • European Devices & Ivd Associates Ltd.
    Medical Device Consultant
    European Devices & Ivd Associates Ltd. Nov 2016 - Present
    United Kingdom And Europe
    Quality Assurance / RA Associate / Complaint Coordinator / CAPA Coordinator / Technical File Information Compiler (CE Marking)
  • Medicina
    Qa/Ra Consultant.
    Medicina Sep 2015 - May 2016
    Bolton, United Kingdom
    Supporting the QA/RA Manager (Interim – EUROPEAN DEVICE SOLUTIONS LTD. SENIOR DIRECTOR).Specifically remediating poor complaints / NC’s / Internal Audits / CAPA records.Also, performing Internal Quality Audits of various departments, and assisting with employee training records / plans prior to an independent Notified Body Assessment to ISO13485 and MDD 93/42/EEC (as amended within 2007/47/EC).
  • European Device Solutions Limited
    Qa / Ra Associate.
    European Device Solutions Limited Apr 2014 - Aug 2014
    United Kingdom
    Various Projects in the CE Marking and US FDA compliance arenas, supporting several European Device Solutions QA/RA senior consultants. Projects in Belgium, Denmark and Essex, on the following activities:EMPLOYMENT HISTORY (cont’d)• Technical File document gathering / compilation (MDD and IVD Directives)• CAPA remediation on-line• Complaint remediation on-line• Vigilance / Recall Reporting• General Admin. Support to Senior Director, etc.
  • Biocartis
    Customer Complaint Coordinator
    Biocartis Mar 2013 - Mar 2014
    Mechelen, Belgium
    Coordinating all activities associated with our IVD Cancer detection device (Apollo). Primary functions include; initial complaint capturing; assignment of unique customer complaint reference number; complaint logging into database; assigning complaint to relevant competency within Biocartis (i.e. software, instrument, cartridge assembly, or assay development team); coordinating the return of faulty instruments via the Biocartis logistics dept. and customer shipping dept’; and liaising with customer and internal Biocartis dept’s throughout the whole complaint resolution process. Primary customers are also our main investors; J&J USA, and BioMerieux France.Also assisting the QA dept. to input Non-Conformances and SCARS (Supplier Corrective Action Requests), PR’s (Problem Reports to design dept.), and CAPA’s.
  • European Device Solutions Limited
    Personal Assistant / Trainee Qa Associate
    European Device Solutions Limited Apr 2010 - Mar 2013
    United Kingdom
    Started out organizing / setting up client meetings; taking company / client information over the telephone; booking flights for our company Director; checking and responding to business emails; typing company letters / proposals to existing / potential clients. After extensive training in London and Belgium with our company, I have supported the company Director to develop Technical Files and QMS systems to IVD/MDD and ISO13485 respectively, for medical device manufacturers (office based). Also acted as primary point of contact for twenty nine (29) US based clients on Complaint Resolution for MDR/Vigilance reporting.

Stephanie Rowden Skills

Microsoft Office Customer Service Microsoft Excel Strategy Cross Functional Team Leadership Microsoft Powerpoint Medical Devices Quality Assurance

Stephanie Rowden Education Details

  • Le Cordon Bleu College Of Culinary Arts-Orlando
    Le Cordon Bleu College Of Culinary Arts-Orlando
    Culinary Arts/Chef Training

Frequently Asked Questions about Stephanie Rowden

What company does Stephanie Rowden work for?

Stephanie Rowden works for Laprosurge Ltd

What is Stephanie Rowden's role at the current company?

Stephanie Rowden's current role is Medical Device Consultant | Co-Director of Fittsisters | Marketing | Chef.

What schools did Stephanie Rowden attend?

Stephanie Rowden attended Le Cordon Bleu College Of Culinary Arts-Orlando.

What skills is Stephanie Rowden known for?

Stephanie Rowden has skills like Microsoft Office, Customer Service, Microsoft Excel, Strategy, Cross Functional Team Leadership, Microsoft Powerpoint, Medical Devices, Quality Assurance.

Who are Stephanie Rowden's colleagues?

Stephanie Rowden's colleagues are Mary Jacobs, Asad Abid, David Campbell, Lucian Vaduva.

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