{"id":1042284,"url":"https://alion.io/job/edwards-lifesciences-quality-engineering-manager","title":"Quality Engineering Manager","company":{"id":5220,"name":"Edwards Lifesciences","domain":"edwards.com","url":"https://alion.io/company/edwards","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":54,"ghost_share":0,"stale_share":0.759,"repost_share":0.037,"time_to_fill_p50_days":27,"computed_at":"2026-10-24T06:02:35Z"}},"role":"Leadership","role_family":"Leadership","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Limerick, Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":75000,"max_usd":169000,"period":"year","method":"role_seniority_country_cell","sample_n":8},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design of Experiments","optional":false},{"name":"GMP","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Microsoft Excel","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-07-03T00:00:00Z","employer_posted_date":"2026-07-03","last_verified_at":"2026-10-22T16:59:20Z","board_verified":true,"closed_at":null,"days_open":113,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":113},"description":"Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.\nThe Role\nManage team to ensure smooth and continuous operations of site quality system, quality control and assurance inspection for in process and finished goods. Oversee process audits and final product release documentation. Advise and facilitate failure investigations, compliance methodologies for manufacturing of valve assemblies Manage team with activities that focus on implementing and optimizing quality engineering practices while ensuring a culture of quality and compliance with global regulatory requirements.\nHow Will You Make an Impact?\nManage supervisors and/or oversee the work of assigned quality assurance team within own function, one or more production line or projects. Develop a robust talent development plan in alignment with functional growth strategies of the department. Identify opportunities and lead the implementation of changes to drive improvements\nManage quality assurance project activities (e.g., CAPA) with the accountability for successful completion of all deliverables to the business within established schedule, scope and quality objectives. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional groups\nCollaborate with cross-functional groups to manage inspection of in-process and finished goods, assemblies and components including proper implementation\nNegotiate solutions with cross-functional groups (e.g., Manufacturing Operations, Supply Chain, and Engineering) for continuous improvement\nManage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design on new products and/or processes. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups\nManage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department\nProvide technical guidance to cross-functional and/or departmental groups to develop and provide design recommendations that integrate into component(s) or product(s) with moderate complexity\nLead the implementation of CAPA program including training, approvals, and system effectiveness\nWhat You Will Need?\nBachelor's Degree in in Science or Engineering field previous related experience Required\nExperience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices or equivalent work experience based on Edwards criteria\nDemonstrated track record in people management or equivalent work experience based on Edwards criteria\nExperience working in a regulated industry or equivalent work experience based on Edwards criteria\nWhat Else We Require?\nProven successful project management leadership skills\nProven expertise in both Microsoft Office Suite, including advanced Excel and related quality systems\nExcellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives\nExpert understanding of quality procedures while addressing issues with impact beyond own team based on knowledge of related disciplines\nExpert understanding of related aspects of quality processes and/or systems\nExpert knowledge of financial acumen as it relates to quality\nExpert knowledge of applicable quality regulations (e.g., cGMP compliance)\nDemonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations\nAbility to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality to the business\nStrict attention to detail\nAbility to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization\nAbility to work and excel within a fast paced, dynamic, and constantly changing work environment\nKnowledge of Lean Manufacturing concepts and Six Sigma\nFrequently interacts with subordinate production supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team\nParticipate and present at meetings with internal and external representatives\nResolve operational and scheduling issues\nDedicated to quality client service and pro-active and responsive to client needs.\nDevelop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.\nDevelop relationships and leverage them to influence change\nSupport and solicit input from team members at all levels within the organization\nAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control\nProven successful project management leadership skills\nExcellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making\nExpert understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines\nExpert understanding of related aspects of quality engineering processes and/or systems\nExpert knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards)\nExpert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing\nKnowledge of financial acumen as it relates to the business as well as quality engineering","description_format":"text","description_chars":6851,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cardiovascular Devices","Patient Monitoring"],"lifecycle":[{"event":"open","at":"2026-09-18T19:51:50Z"}],"visa":[],"liveness":{"score":10,"band":"cold","label":"Long shot","p_open":1,"p_active":0.34,"p_room":0.28,"age_days":113,"expected_fill_days":27,"reasons":["conf:37","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-24T06:02:35Z"},"pay":null,"html_url":"https://alion.io/job/edwards-lifesciences-quality-engineering-manager","json_url":"https://alion.io/job/edwards-lifesciences-quality-engineering-manager.json","meta":{"generated_at":"2026-10-24T13:38:17Z","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":19586,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"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":5220},"rest":"https://alion.io/mcp/rest/get_company?id=5220"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fedwards-lifesciences-quality-engineering-manager"},{"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%2Fedwards-lifesciences-quality-engineering-manager"},{"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%2Fedwards-lifesciences-quality-engineering-manager"},{"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/edwards-lifesciences-quality-engineering-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fedwards-lifesciences-quality-engineering-manager"}]}