Manufacturing Quality Manager
Educated to degree level or equivalent in Quality, Engineering or Science
Knowledge of FDA, ISO 13485 and other regulatory country specific standards
About Our Client
Client has an opportunity for a methodical and organised individual to provide management support to all aspects of clients supplier and manufacturing Quality activity, including Laboratory testing, product release, Quality Engineering and analysis. With experience gained in a similar role, you will develop staff on new quality initiatives and make QA recommendations to ensure best practice. You will provide technical guidance to other internal Quality stakeholders, demonstrating high levels of QA engineering discipline and making appropriate recommendations. You will lead all external regulatory audits and support regulatory submissions requirements to RA in both site and the US as required. You will be expected to provide guidance on completion of non-conforming material reports, deviations and change orders.
The Successful Applicant
Educated to degree level or equivalent in Quality, Engineering or Science, you will have a proven track record within medical device / pharmaceutical / regulated environment combined with knowledge of FDA, ISO 13485 and other regulatory country specific standards. You will be self-motivated, have a proactive approach to work and have the ability to prioritise and plan workloads, whilst meeting tight deadlines. Flexibility around core hours is a must to ensure that high standards are met as is the ability to forge strong working partnerships with key stakeholders and internal client groups.
What's on Offer
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