{"id":4324290,"url":"https://alion.io/job/distalmotion-quality-systems-specialist","title":"Quality Systems Specialist","company":{"id":176322,"name":"Distalmotion","domain":"distalmotion.com","url":"https://alion.io/company/distalmotion","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Epalinges, Switzerland"],"countries":["CH"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-11-14T22:56:07Z","employer_posted_date":"2026-11-14","last_verified_at":"2026-11-14T22:56:07Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"The Quality Systems Specialist is responsible for the development, structure, maintenance, and improvements of the Quality Management System.\nTasks:\nTasks:\n· Lead identification, development, architecture, and optimizations of the Quality Management System, at both Global and Site levels.\n· Work collaboratively and support process owners in reviewing, structuring, and documenting their functional new or improved processes. Structure and integrate multi-referential in the same management system such as IT management system Business Continuity Management system, EHS, finance.\n· Author procedures, policies, work instructions, and related documents with style, content, and format guidelines in compliance with ISO 13485, 21CFR820, EU MDR, MDSAP and other applicable regulations.\n· Actively monitor effectiveness of the quality management system and propose and execute improvement projects.\n· Lead complex quality initiatives (e.g. CAPA, process improvements, new processes, gap analyses, system integrations), make recommendations, develop and execute plans.\n· Plan and conduct internal audits by participating and leading internal audits, follow up on the findings with auditee through effective closure, and present the data for trending.\n· Support electronic QMS transition and take ownership of the software tools including QMS documentation and change control.\n· Support Operational Quality with the handling of non-conformities, tool activities approvals, finish product release.\nRequirements\nRequired abilities :\nDegree in Engineering, Scientific\n5+ years of quality-related system experience in a medical device company developing medical devices\nExcellent technical writing, proofing, and language (grammar and spelling) skills with strict attention to details\nSignificant knowledge of medical device Quality Management Systems (ISO 13485, 21 CFR 820) and regulatory landscape (i.e. MDR)\nCertified lead auditor for ISO 13485\nKnowledge in certification 27001 is a plus\nExcellent communication skills and interpersonal relationship skills\nAdvanced problem-solving, organizational, analytical and critical thinking skills\nElectronic QMS experience is preferred\nFluency in English is a must\nBenefits\nWhat we offer :\nA dynamic, innovative environment with cutting-edge medical technology that is shaping the future of robotic surgery. \nFast-growing Company where innovation meets 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