{"id":4024720,"url":"https://alion.io/job/halma-quality-engineer-quality-auditor","title":"Quality Engineer / Quality Auditor","company":{"id":51550,"name":"Halma","domain":"halma.com","url":"https://alion.io/company/halma","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":87,"open_postings":17,"ghost_share":0,"stale_share":0.529,"repost_share":0,"time_to_fill_p50_days":56,"computed_at":"2026-11-10T06:52:35Z"}},"role":"Finance","role_family":"Finance","seniority":"middle","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Malvern, United States"],"countries":["US"],"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},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false}],"status":"live","first_seen_at":"2026-11-10T16:30:21Z","employer_posted_date":"2026-11-10","last_verified_at":"2026-11-10T16:30:21Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"As a global market leader in the world of eyecare, Keeler’s dynamic business creates an exciting opportunity for career development.\nWe are a vibrant, future-facing organisation, with over a century of industry expertise. The highly-trusted Keeler brand supports our consistent revenue growth. We actively foster a diverse, inclusive work environment and continuously seek to drive sustainability across our organisation.\nKeeler is a part of Halma, a global group of life-saving technology companies focused on growing a safer, cleaner, healthier future for everyone, every day. Employing over 7,000 people in more than 20 countries, Halma has major operations in the UK, mainland Europe, the USA and Asia Pacific. Halma is listed on the London Stock Exchange (LON: HLMA) and is a constituent of the FTSE 100 index.\nYou will be responsible and accountable for the following:\nQUALITY ASSURANCE:\nManage Quality Assurance within Operations, ensuring consistent compliant output in operations, including incoming goods inspection, final build inspection etc.\nDrive and assist quality / operation-based projects.\nAssist with pharmaceutical compliance & quality upkeep / projects / continuous improvement.\nOwn, monitor and improve the Quality Assurance (QA) System within Keeler USA Operations. Reduce waste and increase efficiency of the QA System.\nReview and improve Operations’ quality procedures, standards, and specifications.\nChampion the training and use of relevant quality tools across Keeler.\nRepresent USA Quality Team at Design Change meetings.\nQMS:\nSupport the adoption and ongoing management of the QMS.\nDevelopment of the QMS procedures and associated Work Instructions and documentation.\nCompliance to ISO 13485:2016 and local Pennsylvania / United States regulations and other global requirements.\nUsage of Quality Investigational tools e.g. Five Whys Technique, Fish Bone Technique, Pareto, FMEA, Is/Is Not Analysis, Ishikawa, FMEA to identify the true root cause\nManage, Maintain and Implement CAPAs (Corrective and Preventative Actions).\nContinuously improving processes to promote more agile workflows.\nConduct gap analysis for standards and regulations, when required.\nProvide QMS Induction training for new starters.\nPreparation and delivery of monthly KPI presentations/ Metrics reporting.\nContribute to product Risk Assessment.\nProviding support and guidance in the development and implementation of quality management systems.\nSupport the Global Quality Manager with the merge into global eQMS.\nAUDITS:\nConduct internal and supplier audits, ideally as an ISO 13485:2016 Internal Auditor.\nCo-host Notified Body, regulatory authority and customer audits\nCUSTOMER COMPLAINTS:\nInvestigation and documentation of safety-related complaints (CAPA & Incident Reports).\nOverseeing complaint analysis and reporting complaint trends.\nAssist with incident reporting to regulatory authorities.\nProduct evaluation & testing.\nCustomer liaison and responses, as needed.\nAbout You\nExperience and working knowledge of Quality Assurance\nMinimum 3 years of relevant experience within manufacturing environment, in medical devices, pharmaceuticals, or another highly regulated industry.\nExperience in change control processes.\nQuality Investigational tools e.g. Five Whys Technique, Fish Bone Technique, Pareto, FMEA, Is/Is Not Analysis, Ishikawa, FMEA to identify the true root cause of an event.\nSound knowledge of CAPAs (Corrective and Preventative Actions)\nLead Auditor trained and certified\nAbility to confidently provide QA support across the global business\nWorking knowledge of ISO 13485:2016 and local USA medical device manufacturing and pharmaceutical distribution regulations.\nExperience with Risk Management to ISO 14971\nLocation of this role is based in Malvern, PA, with working from home/travelling hybrid model. Business hours are 8:30 a.m. - 5 p.m., Monday - Friday.\n#Keeler #LI-KK3\nJoin us in creating and delivering life-changing products and solutions that impact millions of people around the world, helping our customers bring an end to preventable vision loss.","description_format":"text","description_chars":4083,"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":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Sensors & Transducers","Access Control & Alarm Systems"],"lifecycle":[{"event":"open","at":"2026-11-10T16:30:21Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"Filed H-1B visas in the last two years","filings_12m":0,"filings_prev_12m":1,"green_card_filings_12m":0,"median_offered_wage_usd":null,"route":null,"cap_exempt":false,"checked_at":"2026-11-10T11:34:35+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":56,"reasons":["conf:0","win:early","comp:brand"],"computed_at":"2026-11-10T17:28:34Z"},"pay":null,"html_url":"https://alion.io/job/halma-quality-engineer-quality-auditor","json_url":"https://alion.io/job/halma-quality-engineer-quality-auditor.json","meta":{"generated_at":"2026-11-10T17:28:34Z","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":6194,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":51550},"rest":"https://alion.io/mcp/rest/get_company?id=51550"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhalma-quality-engineer-quality-auditor"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Fhalma-quality-engineer-quality-auditor"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fhalma-quality-engineer-quality-auditor"},{"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/halma-quality-engineer-quality-auditor\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhalma-quality-engineer-quality-auditor"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4024720}},{"tool":"search_jobs","arguments":{"company":"halma.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4024720},"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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