GE HealthCare Lead Specialist Quality Engineer 

Finland, Kuopio 

442979964

• Ensures quality and regulatory compliance in accordance with documented procedures

• Leads development and implementation of strategy to ensure compliance and product quality

• Ensures process efficiency and compliance

• Drives, influences and supports continuous process improvement

• Drives, influences and supports continuous product quality improvement

• Supports CAPA process

• Performs internal audits and supports external audits

• Bachelor’s Degree or advanced degree

• Experience in Quality Assurance, Quality Engineering or Design Engineering in medical device industry

• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485

• Demonstrated understanding of medical device design controls requirements

• Demonstrated understanding of software development lifecycle, software design change, software process verification and validation methodologies

• Demonstrated knowledge of Quality and Process Improvement tools

• Ability to communicate effectively in English

• Strong technical aptitude

• Ability to handle tasks with competing priorities effectively

• Demonstrated collaboration and conflict resolution skills

• Analytical, problem solving and root-cause analysis skills

• Leader with energy, passion and enthusiasm to drive change

Valid local work permit

• Great opportunity to become a world class Quality Assurance professional of medical devices

• Work with experienced and supportive team of colleagues

• Access to world class processes and professionals across different functions

• Position with possibility to influence in a diverse multicultural working environment.Possibility to grow into different roles in the organization