Company : SHL Group Location : Zug Zoug From : Talent CH
Main Responsibilities Identify risks and possible errors in the process and systems from possible sourcesLead and execute riskmanagement activities for manufacturing processes in developmentLead and execute riskmanagement activities for manufacturing sites in developmentLead and execute riskmanagement activities related to product development — from inception through manufacturing, product launch and scale-upsWork with suppliers on the identification and mitigation of risksSupport creation of Design Verifications, Process and Design Validations plans/reports, as well as development activitiesGuides teams on the risk-based approach to product and process developmentsTake actions to reduce or eliminate risks in product and process design and create resulting Control plansEnsure RMF is compliant to regulatory requirements (21 CFR Part 820, ISO 13485, and ISO 14971)Maintain and continuously improve the RiskManagement processSupport internal and external regulatory audits and inspections.
Minimum qualifications Minimum 7 years of experience in the medical device industryExperience in manufacturing processes development and qualification/validation (molding, automation, metal forming)In-depth knowledge of medical device riskmanagement according to ISO 14971 standard, and experience (3+ years)Fluency in EnglishWorking experience with 21 CFR Part 820, ISO 13485 Preferred qualifications In-depth knowledge of 21 CFR Part 820, ISO 13485, GHTF Guidance, including Risk-Based approaches and Process Validation.In-depth knowledge of techniques, tools and methodologies such as PHA, FMEA, FTA.Experience in application of quality and six sigma methods such as Ishikawa, 5Why, DMAIC, DoE.A solution-oriented growth mindset coupled with decision-making skills.Strong writing and verbal communication skills.Business travel required to max 25%.Medium fluency in German Skills & Qualification Master degree in engineering field.Medium fluency in GermanExperience in applied statisticsKnowledge of Design for Manufacturing and Assembly methodKnowledge of Total Productive Maintenance, Reliability Centered Maintenance methods We Offer A company culture with Focus on Customer, Operate with Ethics and Integrity, Drive Simplicity, Learn and Improve, & Deliver TogetherModern working environment with state-of-the-art facilities and technologiesChallenging assignments in a fast-growing and innovative industryPosition in a dynamic, international team of highly skilled professionalsVarious opportunities for personal and professional development within a global organizationFlexible hours and hybrid working policy SHL Group Zug Zoug
