{"id":3595231,"url":"https://alion.io/job/ambu-senior-qm-rd-engineer-i","title":"Senior QM R&D Engineer I","company":{"id":2093467,"name":"Ambu","domain":"ambu.com","url":"https://alion.io/company/ambu-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Career sitemap","truth_index":{"grade":"A","score":100,"open_postings":3,"ghost_share":0,"stale_share":0,"repost_share":0.333,"time_to_fill_p50_days":9,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["George Town, Malaysia"],"countries":["MY"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":14500,"max_usd":33000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":8444},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false}],"status":"live","first_seen_at":"2026-11-02T02:20:21Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-04T15:11:01Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Ambu A/S is currently looking for a Senior QM R&D Engineer to be based in Penang Ambu Global Hub.\nJoin a dynamic team where your work directly supports medical professionals in solving real-world challenges. This role reports to the Manager, QM R&D and offers a unique opportunity to contribute to innovations that improve patient care. If you're passionate about making a difference and thrive in a problem-solving environment, we’d love to hear from you.\nKey responsibilities\nYour main responsibilities will include:\nParticipate in new product development and project design change for global products. \nParticipate and provide independent oversight on project/ design changes deliverables; review and ensure that project/validation documents comply to regulatory requirements and quality.\nHandle change control, especially be the expert in process validation for global products.\nParticipate in the critical quality issue which required QAE attention in the project as required.\nInvolve in NCR/ CAPA activities as required.\nMaintain the Risk Management files and initiate Process Risk Evaluation during new platform project/ design change.\nOther QM R&D function, as identified.\nSuggested candidate profile\nSkills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:\nDegree in science, engineering or equivalent.\nMin 2 years in Quality Assurance or Quality Engineering.\nKnowledge in ISO13485 and ISO14971.\nExperience in product development, project management and/or design control.\nInnovative, committed with good accountability.\nCandidates from medical device industry will be given priority.\nAmbu - a visionary and international workplace where your efforts matter\nAmbu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.\nWe offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.","description_format":"text","description_chars":2409,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-11-02T02:20:21Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":2,"expected_fill_days":9,"reasons":["conf:0","velocity","win:early","comp:brand"],"computed_at":"2026-11-04T06:34:25Z"},"pay":null,"html_url":"https://alion.io/job/ambu-senior-qm-rd-engineer-i","json_url":"https://alion.io/job/ambu-senior-qm-rd-engineer-i.json","meta":{"generated_at":"2026-11-04T18:30:57Z","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":28486,"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":2093467},"rest":"https://alion.io/mcp/rest/get_company?id=2093467"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fambu-senior-qm-rd-engineer-i"},{"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-senior-qm-rd-engineer-i"},{"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-senior-qm-rd-engineer-i"},{"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-senior-qm-rd-engineer-i\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fambu-senior-qm-rd-engineer-i"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3595231}},{"tool":"search_jobs","arguments":{"company":"ambu.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3595231},"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. Docs: https://alion.io/developers"}}