{"id":1516095,"url":"https://alion.io/job/orthofix-sr-quality-engineer-design-assurance","title":"Sr. Quality Engineer, Design Assurance","company":{"id":1983538,"name":"Orthofix","domain":"orthofix.com","url":"https://alion.io/company/orthofix","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Verona, Italy"],"countries":["IT"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":40000,"max":43000,"currency":"EUR","period":"year","gross":null,"usd_annual":48792},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"FDA 510(k)","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 10993","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false}],"status":"live","first_seen_at":"2026-09-03T00:00:00Z","employer_posted_date":"2026-09-03","last_verified_at":"2026-10-21T17:58:49Z","board_verified":true,"closed_at":null,"days_open":49,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":49},"description":"Why Orthofix?\nGuided by our organizational values - Take Ownership | Innovate Boldly | Win Together - we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.\nOur global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further.\nWe offer an interesting opportunity to join our Quality Engineering team, based in Bussolengo (VR) as Sr. Quality Engineer, Design Assurance, reporting to the Quality Engineering Manager, on a full time contract.\nAs part of the Quality Team, you will be responsible for liasing between Quality Compliance, Quality Management System, Research & Development (R&D) Area and Regulatory Affairs Area during the Design & Development phase of products and their complete lifecycle, including post market surveillance and design changes.\nYou will guarantee that Design & Development activities are conducted in compliance with internal procedures and in conformity with standards, directives and laws applicable to the Organization. You will work in contact with Design & Development Area coordinating specific activities like Risk Management process, design validation, usability and final release.\nWhat will your contribution be?\nManage (i.e. promote, coordinate and document) the Risk Management activities during the Product Development Process, in relation to product modifications and during post-marketing surveillance.\n\nManage (promote, coordinate and document), in cooperation with R&D, Marketing, Medical Science and Clinical Evidence, the usability and design validation about new products, including partecipation to simulated use testing activities;\n\nCooperate with internal departments during the Product Development Process to regulatory release (CE Mark, FDA approval) for:\nnew products (standard products, small series, custom products);\n\nproduct modifications.\n\nSupport Quality Compliance and Clinical evidence areas in the Post-Market Surveillance activities providing contribution to complaints analysis, PSUR, PMCF report and CER in relation to risk analysis, design validation and applicable standards.\n\nCooperate with Regulatory Affairs Area to prepare regulatory submissions (e.g. 510K pre-market notifications), support all the regulatory pre- and post-market activities related to technical aspects and prepare the Technical File documentation;\n\nSupport the R&D Area to formalize:\nProduct requirements definition and review;\n\nProject development plan;\n\nProduce development phase gate documentation;\n\nDesign verification documentation.\n\nImplement and update internal procedures relevant to the above mentioned activities.\n\nSupport the preparation and review of product technical & marketing sheets.\n\nTravel may be needed (10%-15%)\n\nWhat are we looking for?\nPreferred technical degree or master’s degree.\n\nA previous experience of at least 3 years in a similar role is required, preferably in a regulated industry (medical device).\n\nAdvanced knowledge of English and Italian\n\nMethodical and critical thinking.\n\nExcellent organizational and project management skills.\n\nProblem solving skills and proactivity\n\nAbility to work according to procedures, rules and regulations\n\nAdherence to timelines and result oriented attitude\n\nPrecision and attention to detail\n\nAnalytical approach to resolve complex issues\n\nAbility to work in team and autonomously\n\nAccountability for the assigned tasks\n\nKnowledge of relevant regulations (European MDD, MDR, FDA Guidances, ISO 13485, ISO 14971, EN 62366, IEC 62304, IEC 6061, etc.).\n\nKnowledge of relevant standards and application regarding biocompatibility, sterilization, reprocessing and cleaning.\n\nWhat soft skills will you improve?\nAbility to work precisely according to procedures, rules, and regulations\n\nAnalytical mindset, attention to detail, and ability to manage multiple priorities.\n\nGood interpersonal skills and ability to work in cross-functional teams.\n\nAdherence to timelines and result result-oriented attitude\n\nOrderliness and attention to detail\n\nAccountability for the assigned tasks\n\nWhat will you find?\nFriendly, warm, and innovative atmosphere\n\nHealthy, inspiring, and international and inclusive work environment\n\nTraining and development opportunities\n\nSmart working model (two days per week)\n\nCompetitive reward packages\n\nSocial and company events\n\nWellbeing initiatives (welfare)\n\nCanteen\n\nBenefits (Pension Fund- Health Insurance)\n\nWorking Hours: 8:30-17:30 Monday to Thursday and 8:30-16:30 Friday.\n\nWhat we offer?\nThis is a full-time job\n\nThe contract is a permanent contract\n\nSalary package range: 40.000/43.000 euro*\n\n*The package will be evaluated based on the experience of the person\nDo you want to join us? Are you ready to make a difference?\nWe look forward to receiving your application.","description_format":"text","description_chars":5173,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[{"language":"Italian","level":"Advanced (C1)","optional":true},{"language":"English","level":"Advanced (C1)","optional":true}]},"benefits":["Company events","Health insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Consumer Electronics","Health Care","Health & Medical Electronics"],"lifecycle":[{"event":"open","at":"2026-09-30T09:33:41Z"}],"visa":[],"liveness":{"score":59,"band":"ok","label":"Likely open","p_open":1,"p_active":0.789,"p_room":0.75,"age_days":49,"expected_fill_days":51,"reasons":["conf:12","win:late"],"computed_at":"2026-10-22T06:10:10Z"},"pay":{"stated_usd_annual":48792,"is_top_pay":false},"html_url":"https://alion.io/job/orthofix-sr-quality-engineer-design-assurance","json_url":"https://alion.io/job/orthofix-sr-quality-engineer-design-assurance.json","meta":{"generated_at":"2026-10-22T10:22:13Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":7616,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1983538},"rest":"https://alion.io/mcp/rest/get_company?id=1983538"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Forthofix-sr-quality-engineer-design-assurance"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Forthofix-sr-quality-engineer-design-assurance"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Forthofix-sr-quality-engineer-design-assurance"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/orthofix-sr-quality-engineer-design-assurance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Forthofix-sr-quality-engineer-design-assurance"}]}