Quality Assurance Manager

Real Resourcing
North London
£60k - £70k pa + competitive
13 Apr 2017
12 May 2017
Contract Type
Full Time
Quality Assurance Manager / Quality Manager / QA Manager / QMS Manager

London / North London / Hertfordshire

I am partnering with a highly innovative start-up company, specialising in Drug Delivery devices who already have an international presence to find an adaptable, detail oriented Quality Assurance Manager to be based in their HQ in North London.

It's imperative you are hands-on with a "can-do" attitude and work well within a small team and ideally have at least 5 years of experience the Medical Device industry, Drug delivery experience would be a benefit but not a requirement. This company prides themselves on looking after their employees and having a very flexible approach to their work.

This presents an opportunity to join a growing and extremely well financed start-up and truly put your stamp on the business. You will be reporting directly in to the CEO but working closely with all other divisions including Regulatory Affairs, Product Development, Commercial and other C-Level stakeholders.

Key responsibilities:

* Manage the Quality Management System and associated Records
* Act as the companies Quality Representative, such as decision making and coordinating activities around CAPAs; handling of non-conforming product; complaints; quality system reviews; internal and external audits; maintenance of records; data reviews; and other processes associated with the quality system
* Ensure compliance with relevant regulations and guidelines for USA, EU and other markets as needed
* Liaise and coordinate activities with QPs, and people in charge of product release at all stages of the supply chain
* Liaise and coordinate activities with Notified Bodies to obtain relevant certifications
* Provide input and technical expertise during product development, testing, scale-up and commercialisation

Required/Desirable experience:

* Bachelor or higher in a relevant field
* Experience implementing and managing quality management systems for compliance with EU and USA Medical Device regulations and ideally experience of GMP and GLP
* Have a broad experience base including research and development; manufacturing of drug formulation and/or medical devices; regulatory compliance; and applications to and communications with regulatory agencies.
* Have expertise and deep know-how of standards, guidelines and regulations regarding quality systems
* Desirable: Experience setting up and managing GLP and GMP laboratory facilities

If this is an opportunity that could be of interest to you, apply now!

Contact Lillie Fenlon-Billson at l.fenlon-billson @ realstaffing.com