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.
They work closely with functional teams in areas such as Engineering, Order fulfillment, Regulatory Affairs, Sales & Marketing, and Manufacturing among others.
Responsibilities - Work on projects / compliance activities to completion. Prepare monthly metrics for their area of expertise / responsibility.
Analyze process data and trends and drives optimization / improvement. Represent QA organization in specific processes (e.
g. CAPA, Order fulfillment, Manufacturing, etc.) Support others in the QA organization and other functional organizations on technical aspects in order to drive results.
Participate in external audits before regulatory authorities. Participate in the execution of the internal audit plan. Promote and maintain adherence to Elekta values.
Authorities - Preparation of audit plans, execution of audits and preparation of audit reports as applicable. Issuing and supporting closure of non-compliances.
Support processes and procedural changes. Authorize documents and forms. Relevant Knowledge, skills and competEncies - 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.
Strong written and verbal communication skills and ability to collaborate effectively. Objective driven and customer focused.
Capable of producing results working unsupervised under own initiative. Professional integrity. Able to translate regulations into meaningful business requirements.
Possess a structured approach to problem solving with an appreciation of quality tools & techniques. Must be an effective team player with the ability to mentor, lead and problem solve to provide solutions to the business.
Confident and open personality who is able to communicate effectively, both written and orally with people at all levels.
Ability to work efficiently under tight timelines. 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.