Our client is a leader in precision radiation therapy, they are committed to ensuring every patient has access to the best cancer care possible. Our client is a proud innovator and supplier of equipment and software used to improve, prolong, and save the lives of people with cancer and brain disorders.

Responsible for supporting process owners in defining and implementing processes and system changes analyzing process improvements to drive efficiencies. Support the local quality management system and processes. Is an advocate of Quality and promotes the group s vision and mission while supporting the goals of the overall business. You will work closely with functional teams in areas such as Engineering, Order fulfillment, Regulatory Affairs, Sales & Marketing, and Manufacturing among others

Main Duties:

• Work on compliance project / objective activities to completion.


• Prepare monthly metrics for their area of expertise / responsibility.


• Analyse process data, trends and drives optimization / improvement.


• Represent QA organization in specific processes (e.g. CAPA, Order fulfilment, Manufacturing, etc.)


• Support others in the QA organization and other functional organizations on technical aspects in order to drive results.


• Participate in the execution of the internal audit plan.


• Promote and maintain adherence to companies values.


• Issuing and supporting closure of non-compliances.


• Support processes and procedural changes.


• Authorize documents and forms.

Criteria:

• Bachelor s degree in Engineering, Software Engineering or Quality Engineering, or a related field or a formal engineering apprenticeship with demonstrated experience in a similar role


• Training and experience in relevant medical device regulatory requirements and standards (e.g. ISO13485, ISO14971, ISO 63304, IEC, MDR, QSR, CMDR.)


• Proven experience in relevant areas of Quality, Regulatory, Software Engineering or Engineering, preferably within a medical device environment.


• Objective driven and customer focused. Capable of producing results working unsupervised under own initiative and to tight deadlines.


• Professional integrity. Able to translate regulations into meaningful business requirements.


• Possess a structured approach to problem solving with an appreciation of quality tools & techniques.


• Confident and open personality who is able to communicate effectively, both written and orally with people at all levels.


• Proven fluency in English and other applicable languages relevant to their specific geographies.


• Quality professional certifications preferred (e.g. CQI, CQMoE, CQA, CQE.)


• Experience in quality improvement tools and techniques is a plus (e.g. Lean, Six Sigma, DOE, Statistical Methods, etc.)


• Travel may be required.

Job type: Contractor, 3 months, full time

Salary: Up to 45 per hour

Contracted Job Hours: Monday - Friday