{"id":2271577,"url":"https://alion.io/job/ambu-project-quality-engineer","title":"Project Quality Engineer","company":{"id":2093467,"name":"Ambu","domain":"ambu.com","url":"https://alion.io/company/ambu-com","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Career sitemap","truth_index":null},"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":"inferred","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-11T07:28:29Z","employer_posted_date":"2026-10-11","last_verified_at":"2026-10-12T16:56:06Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"A global job position with an impact:\nThe Project Quality Engineer is responsible for providing quality engineering support throughout the product lifecycle, including new product development, design changes, manufacturing transfers, and supplier changes. The role partners closely with R&D, AME, Supply Chain, and Manufacturing to ensure products meet quality, safety, and regulatory requirements in accordance with Ambu's established QMS.\nResponsibilities and Essential Functions:\nEnsure compliance with Design Controls and applicable regulatory requirements.\nDevelop and implement project-specific quality plans and procedures to ensure\nadherence to quality management system, standards and regulations.\nCollaborate with project teams to review and approve design change requests (DCR) and\nassociated quality activity plans (QAP), including required project deliverables\ndocumentation.\nReview and approve validation documentation (including validation plans, protocols and\nsummary reports) to ensure compliance with applicable requirements.\nResponsible for risk management activities and ensuring risk documentation are reviewed\nand updated, as needed.\nMonitor and evaluate project performance metrics to identify areas for improvement and\nimplement corrective actions.\nConduct root cause analysis and implement corrective and preventive actions to address\nquality issues and prevent recurrence.\nEnsure proper documentation and traceability of quality records, including non-\nconformance reports, inspection reports, and corrective action reports.\nTrain project team members on quality standards, processes, and procedures to promote\na culture of quality throughout the projects.\nSupport transfer of products from development to manufacturing, ensuring processes,\nquality controls, and documentation are established prior to release.\nParticipate in project meetings and provide regular updates on quality performance and\nimprovement initiatives.\nStay updated with industry trends, regulations, and best practices in quality management\nto ensure continuous improvement of project quality processes.\nAs assigned, act as a handler for nonconformance reports (NCR) and Corrective\nActions/Preventive Actions (CAPA) activities to drive proper risk evaluation, investigation,\nand implementation of actions.\nSupport internal and external audits as a member of the Internal Audit Team and serve as\na key quality representative during external audits, providing quality system and project-\nrelated support as required.\nAuthorities:\nReject implementing associated documentation change requests related to projects.\nIssue NCR's, CAPA's and SCAR's, as necessary.\nQualifications:\nBachelor's degree in a related field.\n3+ years of Quality Engineering experience in the medical device industry.\nRequired skills\nExperience working within an ISO 13485 and FDA regulated environment.\nStrong understanding of design controls.\nStrong understanding of risk assessment and mitigation strategies.\nFamiliarity with project management methodologies and tools.\nHigh level of time and task management skill.\nMust be able to read, write and understand English.\nAbility to travel as required for project-related activities.\nWork Environment:\nThis is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.\nHow to Apply:\nIf you are interested in the position, then please apply as soon as possible through our recruitment system. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate.\nThis job ad will be online until September 21, 2026, but once we have found the right candidate, this ad will no longer be online. For more information about the position, please feel free to contact at .","description_format":"text","description_chars":3911,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-10-11T07:28:29Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":30,"reasons":["conf:7","win:early"],"computed_at":"2026-10-12T06:55:09Z"},"pay":null,"html_url":"https://alion.io/job/ambu-project-quality-engineer","json_url":"https://alion.io/job/ambu-project-quality-engineer.json","meta":{"generated_at":"2026-10-12T23:57:32Z","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":39381,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-13T00:00:00Z"}},"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":2093467},"rest":"https://alion.io/mcp/rest/get_company?id=2093467"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fambu-project-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%2Fambu-project-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%2Fambu-project-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/ambu-project-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fambu-project-quality-engineer"}]}