{"id":2445601,"url":"https://alion.io/job/proclinical-software-quality-engineer","title":"Software Quality Engineer","company":{"id":2116512,"name":"Proclinical","domain":"proclinical.com","url":"https://alion.io/company/proclinical","size_band":"201-500","is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":null},"role":"QA","role_family":"QA","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":["Perth, Australia"],"countries":["AU"],"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":[],"status":"live","first_seen_at":"2026-10-13T08:58:14Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-10-14T09:28:23Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Keep the heartbeat of innovation running in this Software Quality Engineer position and ensure cutting-edge pharma never miss a beat!\nProclinical is seeking a Software Quality Engineer to contribute to the development and maintenance of technical documentation and ensure compliance with global regulatory and quality standards for Software as a Medical Device (SaMD) products, including AI-enabled software. This role involves collaborating with cross-functional teams to support software lifecycle processes, risk management, and audit readiness.\nResponsibilities:\nSupport and improve software lifecycle processes in compliance with IEC 62304, ISO 13485, and other regulatory requirements.\nParticipate in design reviews, verification/validation activities, risk assessments, and release readiness reviews.\nAssist in software risk management, including hazard analysis and traceability of risk controls.\nMaintain software configuration and change management records for compliance and audit readiness.\nContribute to cybersecurity and Software of Unknown Provenance (SOUP) documentation activities.\nAuthor, update, and maintain technical documentation, including design inputs/outputs and traceability matrices.\nEnsure documentation aligns with regulatory expectations and approved design changes.\nEstablish and maintain end-to-end traceability across requirements, design, risk, implementation, testing, and release.\nDevelop and track documentation plans and timelines aligned with product milestones.\nSupport design and documentation reviews, ensuring outcomes are captured and reflected in technical documentation.\nFacilitate audit and inspection readiness by organizing documentation and ensuring traceability.\nSupport investigations related to software defects, customer complaints, CAPAs, and post-market feedback.\nTrack and manage quality actions, ensuring timely updates to procedures and documentation.\nKey Skills and Requirements:\nBackground in systems engineering, software, or a related field.\nFamiliarity with ISO 13485, FDA 21 CFR Part 820-QMSR, IEC 62304, and ISO 14971.\nExperience authoring technical documentation for SaMD in regulated environments.\nAbility to translate complex engineering and AI-ML concepts into clear, structured documentation.\nStrong technical writing skills with attention to detail and version control.\nProven ability to manage documentation across multiple stakeholders and meet tight deadlines.\nExcellent organizational, coordination, and communication skills.\nFlexibility in working style and problem-solving approach. \nIf you are having difficulty in applying or if you have any questions, please contact Pamela Phoumavong at .\nIf you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.\nProclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.\nBy submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy.","description_format":"text","description_chars":3302,"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":["Biotechnology","Cybersecurity"],"lifecycle":[{"event":"open","at":"2026-10-13T13:26:59Z"}],"visa":[],"liveness":{"score":52,"band":"ok","label":"Likely open","p_open":1,"p_active":0.516,"p_room":1,"age_days":0,"expected_fill_days":45,"reasons":["conf:3","agency","win:early"],"computed_at":"2026-10-14T06:34:16Z"},"pay":null,"html_url":"https://alion.io/job/proclinical-software-quality-engineer","json_url":"https://alion.io/job/proclinical-software-quality-engineer.json","meta":{"generated_at":"2026-10-14T10:19:12Z","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":11948,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-15T00:00:00Z"}},"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":2116512},"rest":"https://alion.io/mcp/rest/get_company?id=2116512"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fproclinical-software-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%2Fproclinical-software-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%2Fproclinical-software-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/proclinical-software-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fproclinical-software-quality-engineer"}]}