Design Quality Assurance Specialist

Job summary
The Design Quality Assurance Specialist will be part of Product Quality Management team.The essential tasks for the team is to assure that the Risk Management process is developed and maintained and that Product Development activities are performed in compliance with our Quality System as well as with applicable Regulations and Standards.The team is also responsible for the Post Market Surveillance process.
Job seniority: mid-to-senior level
Responsibilities
• Assure Quality Planning in product development projects.• Provide guidance for application of Design Control i.e. Design and development planning, Design input (e.g. specifications), Design reviews, Product verification and validation, Risk management, Usability engineering and Design transfer etc.• Provides guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.• Provides support to post market design changes, including assessment of proposed changes using design control methods.• Participate in or lead the completion and maintenance of risk analysis related to product development and quality systems.• Participate in or lead the completion and maintenance of Post Market Surveillance activities, such as data gathering and reporting.• Participates in team projects and assignments, facilitating or leading teams as necessary.• Identifies the opportunities for continuous improvement of the Quality Systems.• Provide Quality System expertise to the organization and ensure compliance to applicable Quality System Regulations by supporting interpretation of regulations, performing gap analysis and lead activities to implement improvements.• Support investigations and resolve Quality System non-conformities (defined during internal and/or external audits).• Train personnel on Quality Management System related topics.
Requirements
• A university degree in medical/technical sciences and significant experience from Quality Management Systems in an IVD/Medical device environment, e.g. QSR, EU medical device directive, ISO 13485, etc.• Experience in Risk Management and Design Controls.• Strong Leadership capabilities, process and customer focused• Strong interpersonal skills, driving cross-functional collaboration• Ability to organize work, can decide about and reach objectives for projects and the processes• Strong analytical problem solving skills• Strong ability to drive tasks/projects to closure in a timely fashion• Excellent verbal/written communication skills in Swedish and English• Experience of working in an international organization and be used to building long term strategies related to Quality