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Join Roche, where every voice matters.OverviewThe Opportunity: We are hiring for a Design Quality Partner to join our Product Development Quality operation to support software and hardware development of new medical devices.ResponsibilitiesPartner with SQP and applicable collaborators to ensure completeness and appropriateness of applicable achievement deliverables to ensure landmark readiness and achievementReview and approve achievement deliverables within development projectsRepresent Pre Market Quality in mQMS Communities and support internal and external auditsDrive standardization of deliverables across all projects and Customer areas (i.e. templates, review process, content, other)Ensure timely execution and quality process management for design change requests, NCs and CAPAModels behavior to support and enable new ways of working and a culture of continuous improvementOther responsibilitiesEmbed and continuously improve knowledge management within Pre Market Quality, fostering effective sharing and retention of knowledge and expertiseEnsure effective change management in Product Development Quality, R&D; and other functionsFoster a culture of innovation and continuous improvement across Product Development Quality and other functionsServe as a role model, supporting the transition to a new operating model emphasizing agility, collaboration, and adaptabilityDrive decision-making, ensuring timely and informed decisions are made, and obtaining commitment for implementationServe as a coach, supporting colleagues to grow and develop their skillsQualificationsBachelor's degree in engineering, business administration or a related field and 3+ years experience or MBA or advanced degree is considered an advantageStrong design control/mQMS understandingKnowledge and understanding of Quality and Regulatory requirements for review of design history fileContentKnowledge of Regulations pertaining to the environment (i.e. ISO *****, FDA, GMP, others)Technical writing and data interpretation skills, including ability to focus on the right degree of detail when reviewing deliverablesPreferred experience in software and hardware for medical devicesLocation: Sant Cugat del VallèsLeadership and Operating PrinciplesPut patients firstFollow the scienceAct as one teamEmbrace differencesAccelerate learningSimplify radicallyMake impact nowThink long termRoche is an Equal Opportunity Employer.DetailsSeniority level: AssociateEmployment type: Full-timeJob function: Quality AssuranceIndustries: Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment ManufacturingEnd of posting#J-*****-Ljbffr