Quality Affairs Manager

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Quality Affairs Manager || Who we areAt TWIICE, we believe that life should be accessible to all. This is why we develop exoskeletons that give people the freedom to do what they love.As a leader in wearable robotics, we keep pushing the boundaries of technology for the benefit of human beings. Fundamentally user-centered, we work everyday towards ever more inclusion through ethical technology. || PositionYou will be responsible for ensuring our compliance with regulatory requirements in the field of medical robotics. You will also oversee the Quality system deployment, maintenance, and compliance throughout the company, as required by the regulatory requirements of the countries operated.The ideal candidate will have at least 3 years of experience in the medical device field, with knowledge of the CE-marking or FDA approval processes.Responsibilities and DutiesTake overall responsibility for Quality and Regulatory Affairs within the companyDrive certification processes and documentation complianceAssist with Quality Management System deployment, maintenance, and compliance throughout the companyDrive compliance of operations and auditability as per internal and/or external requirements.Drive internal training on regulatory requirements, quality processes and applicable standardsThis position is 50% initially but will increase in the next 12 months, and we are looking for a candidate who can commit to growing with the company. We offer flexible working conditions and participation in the employee stock option plan. || About youYou have a proven ability to collaborate across various groups, build relationships and manage effectively in a dynamic organization.Your work ethic is impeccable. You take pride in doing a job well.You are able to set priorities and focus on what is most important.You aspire to make the world a better place, contribute to a more equal and sustainable society. Key qualificationsProven experience in medical device environment, ideally with robotics and/or wearable robotics with the ability to act as "Responsible Person" for the companyAt least 3 years of experience in Quality and Regulatory AffairsExcellent English verbal and written communication skillsPreferred qualificationsExperience with CE marking or FDA approval processesAbility to converse in French or willing to learnExperience in the field of wearable roboticsMaster’s degree or PhD in engineering || What we offerAn opportunity to make the world a better place and to have a major impact on people's life.Growth potential. We highly value team members who have an outsized impact and provide rapid advancement opportunities. Flexible working time and conditions: our employees make their workplace one they love. Participation in the employee stock option plan.Office locationALTContactTWIICE SA, Rue de Lausanne 64, 1020 RenensE-mail: careers@twiice.comPhone: +41 21 539 1234Website: www.twiice.comTWIICE provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to ethnicity, religion, gender, national origin, age, disability or marital status. #J-18808-Ljbffr

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