{"id":3890395,"url":"https://alion.io/job/materialise-quality-engineer","title":"Quality Engineer","company":{"id":54388,"name":"Materialise","domain":"materialise.com","url":"https://alion.io/company/materialise","size_band":"1001-5000","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":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":["United States"],"countries":["US"],"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":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-11-06T21:04:14Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-07T02:27:14Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"At Materialise Medical, we believe that better healthcare starts with solutions designed around the individual patient. If you’re passionate about bringing personalized care to every patient, you’ll love being a part of this team. Through the technology we develop, researchers, engineers, and clinicians are revolutionizing personalized treatment - helping improve and save lives daily.\nKey Responsibilities:\nEnsure implementation of the quality management system with compliance with regulatory requirements (FDA/QSR/MDSAP), standards (ISO 13485) and customer needs. Assist in supporting the quality management system and quality policy to achieve and maintain the highest level of quality while enhancing value for our customers, driving innovation, growing infrastructure and knowledge and increasing service and product functionality and quality. \nProvide Quality afternoon support for the medical unit, assisting with writing, reviewing and approving standard operating procedures to ensure regulatory compliance. \nReview engineering change orders, non-conformance reports, process qualifications, product disposition requests, pre-release product reviews, risk analysis, health hazard analysis, and quality-related issues. \nProvides statistical trend analysis on the quality management system. Monitor, evaluate and investigate processes to identify potential deficiencies, communicate these issues and initiate additional actions to resolve quality-related issues. Manage and monitor to ensure deficiencies are resolved and corrective/preventive actions are implemented and effective. \nReviews, writes or performs quality system verification/validations. \nLiaise with the company regulatory experts to ensure that we comply with any necessary standards.\nIdentify process improvements or breaches, document and track them through to resolution.\nPerform internal audits to ensure company is adhering to its processes.\nOrganize and minute the necessary quality meetings.\nRequired Skills & Qualifications:\nDegree educated in Engineering, Computing, Science, Medical or Mathematical Based Discipline.\nExperience\nApplicant should be an experienced quality engineer in managing a quality system, with particular experience ISO 13485 and FDA Regulations. \nAbility to analyse regulatory documentation and to derive the necessary changes needed to conform.\nDemonstrated understanding of the importance of quality - including good practices, understanding of the importance of process and documentation.\nExperienced in delivery of quality systems in a software environment.\nKnowledge of key medical software regulation practices and procedures and the auditing processes associated with them.\nPossession of good communication skills.\nGreat attention to detail and quality first mentality.\nWhat’s waiting for you\nWork that matters \nThe technology we build at Materialise pushes the boundaries. You’ll find pride in building something that matters, whether you designed it, printed it, or shipped it. No matter your role, we unlock new possibilities to build a better and healthier world every day.\nAt Materialise, we expect you to think about the customer, not just the task. You push for better solutions and care about the difference your work makes.\nA people-centered space \nWhen you join Materialise, you join a group of colleagues invested in you, not just your work. From your own team to a department across the world, you’ll find a sense of belonging with people who help without being asked, challenge you, and have your back.\nAt the same time, we expect you to invest in the people around you - not just your own work - to make the group stronger than the sum of its parts.\nAn environment of trust \nAs a company of innovators, we know how crucial autonomy is in your work. When we hire you, we trust in your expertise, giving you space to organize your tasks, work flexibly, and make your own calls.\nAt Materialise, we expect you to deliver on that trust and keep your commitments.\nA career ready to build \nWhen you see opportunities for your career to grow at Materialise, we encourage you to go for them. People shape a fulfilling career at their own pace here.\nAt Materialise, we expect you to take initiative in your own development. Don’t wait for someone else to plan your career. Step into the space and make it count.\nMake a difference together with the Medical team.","description_format":"text","description_chars":4381,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CAD, PLM & BIM Software","3D Printers & Additive Manufacturing","Orthopedic & Spine Implants"],"lifecycle":[{"event":"open","at":"2026-11-06T21:04:14Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 1 · green card filings: 1","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":1,"median_offered_wage_usd":150000,"route":null,"cap_exempt":false,"checked_at":"2026-11-07T07:57:00+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":0,"expected_fill_days":50,"reasons":["conf:3","velocity","win:early"],"computed_at":"2026-11-07T05:47:08Z"},"pay":null,"html_url":"https://alion.io/job/materialise-quality-engineer","json_url":"https://alion.io/job/materialise-quality-engineer.json","meta":{"generated_at":"2026-11-07T17:20:47Z","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":25302,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-08T00:00:00Z"}},"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":54388},"rest":"https://alion.io/mcp/rest/get_company?id=54388"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmaterialise-quality-engineer"},{"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%2Fmaterialise-quality-engineer"},{"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%2Fmaterialise-quality-engineer"},{"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/materialise-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmaterialise-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3890395}},{"tool":"search_jobs","arguments":{"company":"materialise.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3890395},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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