Quality Manager

Our client, a market leading medical device company designing, developing, and manufacturing drug delivery devices across the globe are leading the way in drug delivery device innovation, driven by customer and patent demand, offering the potential to create new treatments and opportunities worldwide.

Quality Manager

As Quality System Manager you take responsibility for internal as well as external audits, documentation control, non-conformances, CAPA process along with change controls. You will establish and maintain the quality management systems including the implementation and maintenance of new tools that will enable the business to meet regulatory, customer and company requirements while having a large input on process control.

Quality Manager Responsibilities:

• Prioritise the health and safety, as well as the quality guidelines within the working environment ensuring the highest overall product quality
• Take responsibility for the quality management system and the management review process
• Maintain and continuously improve NCR's and CAPA processes to ensure the reduction of product failures
• Manage and coordinate all internal and customer audits to ensure conformity to regulatory and company compliance
• Coach and influence at all levels so that best practice is understood and that all activities reflect an efficient QMS
• Communicate and train employees in relevant procedures to ensure understanding and consistency is applied in line with policies

Quality Manager Requirements:

• STEM degree required in a relevant field or considerable experience of managing quality management systems within the medical device sector
• Experience with GMP requirements, ISO 13485 or 21 CFR part 820
• Experience of internal and external audits
• Experience implementing an electronic quality management system
• Computer literate with the skills to design and implement computerised infrastructure
• Working knowledge of statistical skills including design or experiments, R&R and capability indices
• Team collaboration skills with proven leadership/management

This opportunity will allow a driven Quality System Manager to have a large impact on the overall business functions moving forward by improving current systems as the pillars of the business change for wider internal production and development. As an integral part of the business you will be rewarded with competitive salary options, comprehensive benefits package and further career development.

If this opportunity is of interest, please apply with an up-to-date CV.