Compliance Assistant

Working within the Customer Solutions group, you will be part of a team dealing with quality and compliance activities supporting customers. Reviewing records related to field activities supporting the EMEA customer base (RUO and IVD) you’ll focus on monitoring & reviewing DCP records (assets, case and work order information) for compliance. In the context of Quality Management System (QMS) ISO13485, you will work in close collaboration with the quality/regulatory teams as well as your colleagues from the field and internal support teams to promote continuous quality improvement.

Your customers are at the forefront of genetics and NGS (Next Generation Sequencing), helping to deliver advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. Your new colleagues are all passionate about what they do, knowing that their work has the power to improve lives.

If you want to push boundaries and join a culture fuelled by innovation, collaboration and openness. If you want a brilliant, fast-paced, mission-driven environment, then Illumina is the place for you. 

Responsibilities will include:

·        Perform Installation Qualification/Operational Qualification (IQ/OQ) reviews and qualifications for the EMEA region 

·        Develop and assist in implementing the reviewing cycle for installed product records in DCP for accuracy and compliance

·        Assist in reviewing quality records in DCP when required 

·        Communicate any compliance risks noted from these activities to management

·        Assist in monitoring key compliance metrics identified for the Customer Support Solution group

·        Work with Quality and compliance team to continuously educate the EMEA service and support team on the importance of QMS and facilitate implementation of best practices

·        Development of standardised guidance documents for the customer support group

 

Preferred background, skills and experience:

·        Basic technical/engineering background

·        Experience in quality systems is preferred

·        Meets deadline, effective use of time and handle multiple assignments simultaneously

·        good eye for detail

·        Exceptional interpersonal and collaboration skills

·        Understanding of service and field activity

 

 
 

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