{"id":1159551,"url":"https://alion.io/job/abbvie-senior-quality-engineer-design-quality-lifecycle-management-2","title":"Senior Quality Engineer- Design Quality – Lifecycle Management","company":{"id":3660,"name":"AbbVie","domain":"abbvie.com","url":"https://alion.io/company/abbvie","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":{"grade":"B","score":80,"open_postings":63,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":16,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Chicago, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":78500,"max":141000,"currency":"USD","period":"year","gross":null,"usd_annual":141000},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"closed","first_seen_at":"2026-09-23T21:02:13Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-09-30T16:40:58Z","board_verified":false,"closed_at":"2026-09-30T16:40:58Z","days_open":6,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":6},"description":"About AbbVie\nAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.\n Sr. QE for Design Quality - Lifecycle Management\nResponsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetic Devices, etc.\nResponsibilities:\nPerform QA activities related to Combination Product and Medical Device Design Transfer and Change Management:Ensure compliance with company policies and procedures.\nPerform design control and risk management activities according to AbbVie's Quality System\nMaintain DHF documentation\nPartner within Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met\nPerform 3rd party supplier management activities such as review 3rd party design control activities\nSupport the creation of regulatory submission documentation\n\nServes as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of AbbVie.\nSupport equipment qualifications (IQ/OQ/PQ) and process validations\nOwn change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor them to ensure timely closure\nIdentify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.\nInitiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.\nActively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents\nApply knowledge of global regulations, guidance's, and Corporate and Function standards.\nLead/assist in the preparation of and support regulatory agency and internal audits.\nConduct, lead, or participate in investigations and review boards for CAPAs, NCRs, Observations, etc.\nParticipate in departmental Change Control activities, utilizing Design Control knowledge to perform design change impact assessments.\nReview and approve changes relevant to the department\nSupport interactions with regulatory authorities (e.g., Notified Body audits)\nWrite and revise procedures, forms, and other documents, as needed\nWork with the cross-functional team to drive change and continuous improvement\n Bachelor's degree, preferably in Biology, Chemistry or Engineering\n6+ years of overall experience in Manufacturing, Quality or Engineering\nGood verbal and written communication skills.\nGood problem solving and analytical skills\nGood interpersonal relations / communications skills\nGood negotiation skills\nKnowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.\n Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:\nThe compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.\n\nWe offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.\n\nThis job is eligible to participate in our short-term incentive programs.\n\nNote: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.\nAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.\nUS & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html\nUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:\nhttps://www.abbvie.com/join-us/reasonable-accommodations.html","description_format":"text","description_chars":5457,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Neurology & CNS Therapeutics","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-23T23:04:51Z"},{"event":"close","at":"2026-09-30T16:40:58Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 236 · green card filings: 57","filings_12m":236,"filings_prev_12m":256,"green_card_filings_12m":57,"median_offered_wage_usd":150555,"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":null,"pay":{"stated_usd_annual":141000,"is_top_pay":true},"html_url":"https://alion.io/job/abbvie-senior-quality-engineer-design-quality-lifecycle-management-2","json_url":"https://alion.io/job/abbvie-senior-quality-engineer-design-quality-lifecycle-management-2.json","meta":{"generated_at":"2026-10-25T19:40:47Z","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":27875,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"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":3660},"rest":"https://alion.io/mcp/rest/get_company?id=3660"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fabbvie-senior-quality-engineer-design-quality-lifecycle-management-2"},{"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%2Fabbvie-senior-quality-engineer-design-quality-lifecycle-management-2"},{"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%2Fabbvie-senior-quality-engineer-design-quality-lifecycle-management-2"},{"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/abbvie-senior-quality-engineer-design-quality-lifecycle-management-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fabbvie-senior-quality-engineer-design-quality-lifecycle-management-2"}]}