{"id":3105914,"url":"https://alion.io/job/philips-quality-management-systemcapa-specialist","title":"Quality Management System/CAPA Specialist","company":{"id":13838,"name":"Philips","domain":"philips.com","url":"https://alion.io/company/philips-2","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":62,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":9,"computed_at":"2026-10-26T05:57:25Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bothell, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":102480,"max":163968,"currency":"USD","period":"year","gross":null,"usd_annual":163968},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-10-22T19:11:01Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-25T00:35:16Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Job Title\nQuality Management System/CAPA SpecialistJob Description\nFor the Personal Health QMS Audit and CAPA team we're looking for an experienced Quality Management System (QMS)/CAPA Specialist, who will be responsible for facilitation of the CAPA process and supporting Audit Readiness activities to ensure an efficient/compliant Quality Management System (QMS). This includes monitoring process performance, preparing detailed reports, presenting findings to senior management and active participation in continuous improvement activities.\nYour role:\nTakes ownership of processes in the assigned area/ areas (CAPA, Audit Readiness and related Document Control, Training) to ensure that QMS is efficient and meets the regulatory requirements.\nAnalyzes QMS metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management.\nWorks under limited supervision and broad guidelines, regularly applying independent judgment on matters of significance to drive project success and compliance.\nContributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards.\nConducts risk assessments activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and developing robust mitigation strategies to minimize their impact.\nParticipates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.\nApplies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team, ensuring effective solutions and innovative approaches to complex challenges.\nParticipates in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.\nCultivates effective relationships with internal and external partners, providing influence over projects and peer groups by demonstrating a comprehensive understanding of the area of specialization.\nLeads cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.\nPrepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.\nYou're the right fit if:\nYou have a minimum of 3+ years’ experience in CAPA management, Quality Management Systems, Quality Audits in highly regulated environments/industries such as Medical Device, Pharma or Automotive. FDA regulated Medical Device preferred.\nYou have proven knowledge of global medical device regulations, requirements, and standards, such as QMSR, ISO 13485, ISO 9001, and EU MDR-preferred.\nYou have detailed experience/knowledge of the CAPA process, including problem identification, root cause analysis, corrective action planning, effectiveness verification, technical writing and CAPA timeliness management. You train and support CAPA teams accordingly.\nYou’re experienced in Data analysis, detailed reporting of QMS metrics/KPI’s, highlighting trends, deviations, areas for improvement, and presenting findings to senior management.\nYou’re able to build/cultivate relationships with supervisors, functional peer groups, and internal/external stakeholders.\nYou have a minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines. ASQ-CQE certification-desired.\nYou must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. \nHow we work together:\nWe believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time (5 days per week) presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office-based role.\nAbout Philips:\nWe are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.\nLearn more about our business.\nDiscover our rich and exciting history.\nLearn more about our purpose.\nLearn more about our culture.\nPhilips Transparency Details:\nThe pay range for this position in Bothell, WA is $102,480 to $163,968.\nThe actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.\nAt Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.\nIn addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.\nAdditional Information:\nUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.\nCompany relocation benefits WILL NOTbe provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA.\n#LI-PH1\nThis requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.\nPhilips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.","description_format":"text","description_chars":6459,"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":[]},"benefits":["401k plan","Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Health & Medical Electronics","Respiratory & Sleep Devices","Patient Monitoring","EHR & Clinical Software"],"lifecycle":[{"event":"open","at":"2026-10-22T19:11:01Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 29 · green card filings: 19","filings_12m":29,"filings_prev_12m":54,"green_card_filings_12m":19,"median_offered_wage_usd":128438,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":56,"band":"ok","label":"Likely open","p_open":1,"p_active":0.623,"p_room":0.9,"age_days":3,"expected_fill_days":9,"reasons":["conf:29","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-26T05:57:25Z"},"pay":{"stated_usd_annual":163968,"is_top_pay":true},"html_url":"https://alion.io/job/philips-quality-management-systemcapa-specialist","json_url":"https://alion.io/job/philips-quality-management-systemcapa-specialist.json","meta":{"generated_at":"2026-10-26T13:36:30Z","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":18920,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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":13838},"rest":"https://alion.io/mcp/rest/get_company?id=13838"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fphilips-quality-management-systemcapa-specialist"},{"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%2Fphilips-quality-management-systemcapa-specialist"},{"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%2Fphilips-quality-management-systemcapa-specialist"},{"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/philips-quality-management-systemcapa-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fphilips-quality-management-systemcapa-specialist"}]}