{"id":3463793,"url":"https://alion.io/job/hello-kaleido-quality-engineer","title":"Quality Engineer","company":{"id":3781871,"name":"Hello Kaleido","domain":"hellokaleido.com","url":"https://alion.io/company/hellokaleido","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Recruitee","truth_index":{"grade":"B","score":75,"open_postings":6,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Utrecht, Netherlands"],"countries":["NL"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":49000,"max_usd":86000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":31},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Design Controls","optional":false},{"name":"EU MDR","optional":false},{"name":"ISO 13485","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Minitab","optional":false}],"status":"live","first_seen_at":"2026-10-29T14:08:04Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-04T05:55:14Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Join ViCentra - Empower Bold Change in MedTech\nLocation: Utrecht, the Netherlands\nHybrid\nMaking Every Move Matter\nAt ViCentra, we’re on a mission to make living with diabetes easier, by designing simple, beautiful, and effective solutions that fit people’s lives, not the other way around. We combine technological innovation with human-centered design to empower people with more freedom, confidence, and life on their terms. Our values; Be Bold, Build Trust, Focus on the Customer and Deliver Excellence drive everything we create and every decision we make.\nWe believe that when ambition meets purpose, remarkable things happen. If you thrive in a space where ideas accelerate, challenges spark growth, and making a difference is the goal, ViCentra is your next great adventure.\nYour Impact\nAs Quality Engineer, Process Validation, you'll make sure the processes behind our insulin pump technology are proven, repeatable and ready to scale. You'll drive validation across processes, methods, equipment and specifications, working hand in hand with R&D, Manufacturing, Regulatory, suppliers and CMOs to bring products safely from development through design transfer and into production.\nThis is where rigour becomes trust. Every validated process is a promise to people living with diabetes that their device will perform, every time. As part of Quality & Regulatory Affairs, your work won't stop at individual projects: you'll help raise the bar for quality across the whole organisation as ViCentra grows.\nWhat You’ll Take On\nIn your role, you will:\nDrive and support validation activities (IQ/OQ/PQ, TMV) on processes, methods, equipment and specifications, including documentation review and approval.\n\nBring a quality lens to product and process development, design transfer and technology projects.\n\nPartner with Manufacturing, R&D, Quality, Regulatory, suppliers and CMOs to develop and improve quality controls and documentation.\n\nDevelop and implement inspection processes and test methods.\n\nSupport Change Control for design, development and manufacturing changes.\n\nApply statistical techniques to analyse validation data and turn results into clear, defensible decisions.\n\nKeep our work compliant with ISO 13485, EU MDR and QMSR (21 CFR 820), as well as internal procedures.\n\nContribute to project management, and potentially lead projects within the QE team, keeping deadlines and deliverables on track.\n\nRequirements\nWhat You Bring\nA Bachelor's degree in Quality, Mechanical or Biomedical Engineering, Health Sciences, or equivalent practical experience.\n\n3 to 5 years of experience in Quality Engineering, preferably within medical devices or another regulated industry.\n\n3 to 5 years of hands-on process validation experience (IQ/OQ/PQ, TMV).\n\nSolid knowledge of statistical techniques and experience with Minitab or similar data analysis software.\n\nDeep understanding of quality control principles, quality management systems and risk management.\n\nExcellent grasp of ISO 13485, EU MDR and QMSR (21 CFR 820).\n\nFluent written and spoken English (Dutch is not required), plus strong Microsoft Office and general IT skills.\n\nA self-starting, resolution-focused mindset, with a sharp eye for detail and strong collaboration skills.\n\nExperience with Design Control, cleanroom standards or sterilisation processes (Gamma, EtO), or a start-up or scale-up environment, is a strong plus.\n\nLife at ViCentra\nWorking at ViCentra means joining a team defined by:\nCourage to create: We experiment, challenge norms, and learn fast.\n\nTrust above all: Integrity, honesty, and openness shape our relationships.\n\nCustomer-first mindset: Every idea is measured by the impact on those we serve.\n\nA drive for excellence: We hold ourselves to the highest standard because lives depend on it.\n\nOur days move fast, fueled by curiosity, diverse perspectives, and a love for collaboration. Here, you can shape and be shaped by groundbreaking work in MedTech.\nGrow With Purpose\nHarness your talent for a mission that truly matters.\n\nEnjoy creative freedom, supportive teamwork, and room to lead initiatives.\n\nMake a direct impact in people’s lives, today and into the future.\n\nBe surrounded by innovators who challenge and cheer you on.\n\nEvery Journey Starts Somewhere - Make Yours Count Here\nWe believe a powerful team is built on unique backgrounds and points of view. If this opportunity excites you but you’re unsure if you fit every bullet, we want to hear your story. At ViCentra, it’s your potential and passion that catch our eye.","description_format":"text","description_chars":4527,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Netherlands","iso":"NL","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Health & Medical Electronics","Diabetes Devices"],"lifecycle":[{"event":"open","at":"2026-10-29T14:45:38Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":5,"expected_fill_days":30,"reasons":["conf:0","win:early"],"computed_at":"2026-11-04T06:34:25Z"},"pay":null,"html_url":"https://alion.io/job/hello-kaleido-quality-engineer","json_url":"https://alion.io/job/hello-kaleido-quality-engineer.json","meta":{"generated_at":"2026-11-04T07:00:41Z","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":10972,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"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":3781871},"rest":"https://alion.io/mcp/rest/get_company?id=3781871"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhello-kaleido-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%2Fhello-kaleido-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%2Fhello-kaleido-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/hello-kaleido-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhello-kaleido-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3463793}},{"tool":"search_jobs","arguments":{"company":"hellokaleido.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3463793},"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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