{"id":3765900,"url":"https://alion.io/job/johnson-johnson-staff-quality-systems-engineer","title":"Staff Quality Systems Engineer","company":{"id":14152,"name":"Johnson & Johnson","domain":"jnj.com","url":"https://alion.io/company/jnj","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":89,"open_postings":231,"ghost_share":0,"stale_share":0.628,"repost_share":0.004,"time_to_fill_p50_days":10,"computed_at":"2026-11-06T05:58:05Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"staff","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Danvers, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"EU MDR","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false}],"status":"live","first_seen_at":"2026-11-04T20:04:11Z","employer_posted_date":"2026-11-04","last_verified_at":"2026-11-06T06:23:21Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com\nAs guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.\nJob Function:\nQualityJob Sub Function:\nQuality SystemsJob Category:\nProfessionalAll Job Posting Locations:\nDanvers, Massachusetts, United States of AmericaJob Description:\nWe are searching for the best talent for a Staff Quality Systems Engineer to lead and optimize CAPA and Nonconformance (NC) processes within a regulated medical device environment. This role will be based in Danvers, MA.\nPurpose: This role is instrumental in driving quality system improvements, ensuring global regulatory compliance, and mentoring junior engineers. The position includes travel to support cross-site initiatives, supplier quality activities, and audit readiness.\nYou will be responsible for:\nLead complex investigations of product and process nonconformances using advanced root cause analysis methodologies (e.g., Fault Tree Analysis, 5 Whys, Fishbone, DOE).\nOversee the end-to-end CAPA and NC process, ensuring timely execution, thorough documentation, and effective implementation of corrective and preventive actions.\nServe as a subject matter expert (SME) for CAPA and NC processes during internal audits, FDA inspections, and Notified Body assessments.\nAnalyze CAPA/NC trends and metrics to identify systemic issues and recommend strategic quality improvements.\nCollaborate with cross-functional teams including Manufacturing, R&D, Regulatory Affairs, and Supplier Quality to resolve quality issues and implement sustainable solutions.\nSupport risk management activities in accordance with ISO 14971, including risk assessments related to CAPAs and NCs.\nMentor and train junior quality engineers and other stakeholders on CAPA/NC processes, regulatory requirements, and quality tools.\nContribute to the development and continuous improvement of the Quality Management System (QMS), including SOPs, work instructions, and templates.\nLead or support global harmonization initiatives for CAPA/NC processes across multiple sites or business units.\nUp to 10% travel may be required to support:Regulatory inspections and internal audits at other facilities\nTraining and collaboration with global teams\n\nQualifications/Requirements:\nBachelor’s degree in engineering, Life Sciences, or related field; advanced degree preferred.\nMinimum 5-7 years of experience in quality engineering /quality systems within the medical device industry.\nDeep understanding of FDA QSR (21 CFR Part 820), ISO 13485, and EU MDR.\nProven experience managing CAPAs and NCs in a regulated environment.\nStrong analytical skills and proficiency in quality tools (e.g., 8D, FMEA, Six Sigma, Lean).\nExperience with electronic QMS platforms (e.g., EtQ,SAP).\nExcellent communication, leadership, and project management skills.\nCertified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Lean Six Sigma Black Belt or similar preferred. \nExperience with complaint handling, design controls, and post-market surveillance preferred. \nFamiliarity with global regulatory requirements (e.g., USFDA, Health Canada, TGA, PMDA) preferred. \nAbility to influence cross-functional teams and drive quality culture preferred. \nJohnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.\nJohnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.\nRequired Skills:\nPreferred Skills:\nThe anticipated base pay range for this position is :\n$96,000.00 - $155,250.00Additional Description for Pay Transparency:\nSubject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:\nVacation -120 hours per calendar year\nSick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year\nHoliday pay, including Floating Holidays -13 days per calendar year\nWork, Personal and Family Time - up to 40 hours per calendar year\nParental Leave - 480 hours within one year of the birth/adoption/foster care of a child\nBereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year\nCaregiver Leave - 80 hours in a 52-week rolling period10 days\nVolunteer Leave - 32 hours per calendar year\nMilitary Spouse Time-Off - 80 hours per calendar year\nFor additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits","description_format":"text","description_chars":6075,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Military spouse friendly","Parental leave","Retirement plans"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"},{"name":"Washington","iso":null,"kind":"city"},{"name":"Colorado","iso":null,"kind":"city"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Surgical Instruments & Devices","Orthopedic & Spine Implants"],"lifecycle":[{"event":"open","at":"2026-11-04T20:04:11Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 66 · green card filings: 18","filings_12m":66,"filings_prev_12m":43,"green_card_filings_12m":18,"median_offered_wage_usd":166964,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+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":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":1,"expected_fill_days":10,"reasons":["conf:4","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-06T05:58:05Z"},"pay":null,"html_url":"https://alion.io/job/johnson-johnson-staff-quality-systems-engineer","json_url":"https://alion.io/job/johnson-johnson-staff-quality-systems-engineer.json","meta":{"generated_at":"2026-11-06T09:44:51Z","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":17672,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"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":14152},"rest":"https://alion.io/mcp/rest/get_company?id=14152"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fjohnson-johnson-staff-quality-systems-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%2Fjohnson-johnson-staff-quality-systems-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%2Fjohnson-johnson-staff-quality-systems-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/johnson-johnson-staff-quality-systems-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fjohnson-johnson-staff-quality-systems-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3765900}},{"tool":"search_jobs","arguments":{"company":"jnj.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3765900},"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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