Quality Assurance Associate EMEA

Job description

JOB DESCRIPTION:

We are recruiting a Quality Assurance Associate EMEA to be based in our offices in Zaventem.

The purpose of the job is to assist country offices with change control, document control, training, KPIs, audit follow-up and alignment of the local Quality System with the EMEC Quality System. The Quality Assurance Associate also support the Quality Assurance Manager in the implementation and maintenance of the quality system in EMEAC.

Your role and responsibilities include:

• Monitoring compliance of the EMEA QMS to external quality and regulatory requirements, ensuring SOPs and instructions are aligned and changes are processed through Change request and document control process.
• Performing internal audits and supplier assessments according to the internal audit program.
• Supporting preparation to external audits, assist Mgr. Quality Assurance EMEA during external audits.
• Supporting on set-up and monitoring of trainings for EMEA regions.
• Supporting and monitoring metrics for certain quality related processes (change control, training).
• Providing effective QA Introduction Training, ISO 13485 intro training and SOP trainings to new employees under EMEA QMS.
• Following-up and monitoring of Calibration schedules within EMEA to ensure required devices are timely calibrated.
• Taking ownership in specific QMS continuous improvement projects as assigned and agreed with line manager.
• Ensuring Quality SharePoint remains up to date.
• Supporting quality control processes within EMEA QMS: CAPA, Change Control, Risk Management, Deviation handling, Supplier assessment and evaluation, etc.
• Monitoring and following up on timely submission and completion of corrective actions to Audit observations in EMEA.
• Supporting in development, follow-up and implementation of Quality Plans.

Your profile:

• University degree, graduated science, or equivalent work experience
• Experience with Quality Systems
• Experience in internal audits is a plus
• Knowledge of the MDR and ISO 13485 requirements is preferred
• Working proficiency in English language
• Extensive MS Office skills, computer literacy
• Team player
• Ability to respect confidential nature of information
• Focused on maintenance of effectiveness of processes
• Good communication skills
• Willingness to travel up to 20% within EU

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: