{"id":3853593,"url":"https://alion.io/job/planet-pharma-sr-quality-engineer-3","title":"Sr. Quality Engineer","company":{"id":4467183,"name":"Planet Pharma","domain":"planet-pharma.com","url":"https://alion.io/company/planet-pharma","size_band":null,"is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":{"grade":"B","score":80,"open_postings":11,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":15,"computed_at":"2026-11-07T05:47:08Z"}},"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":["Eagan, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design History File","optional":false},{"name":"EU MDR","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Microsoft Excel","optional":false}],"status":"live","first_seen_at":"2026-10-12T00:00:00Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-07T21:27:49Z","board_verified":true,"closed_at":null,"days_open":27,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":27},"description":"Job Summary:\nThe Sr. Quality Engineer develops, establishes, and maintains Quality Engineering methodologies, systems and practices that meet quality and customer requirements. The Sr. QE drives quality improvements focused on New Product Introductions, Product Transfers and Marketed Product Support. This position will provide sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Supports quality improvement, disciplines, decisions, and practices. The Sr. Quality Engineer will manage and/or provide guidance to product sterilization, product testing, control environment/cleanroom testing, and actively participate in document changes, Corrective and Preventive Actions (CAPAs) and Complaints and Nonconforming Material Review process.\nDuties:\n* Follow all regulations, standards, procedures, and work instructions defined in the Quality System Manual \n* Sound knowledge of inspection principles and techniques\n* Sound knowledge of validation principles\n* Ability to interpret Quality Standards for implementation\n* Manage and/or provide guidance to product sterilization, product testing and control environment/cleanroom testing.\n* Analytical Problem Solving- ability to identify problems, define problem statements clearly and accurately, apply structured and disciplined methodology to identify data-driven root causes\n* Manage and/or investigate and document CAPAs\n* Update or create procedures, work instructions, forms and labels using Word, Excel, Label View, etc. \n* Review and release sterile product\n* Review document changes as assigned \n* Support the compilation of technical and design history files\n* Participate in external, internal, supplier and design history file audits, as needed\n* Assign and review deviations.\n* Support inspections and audits performed by Customers, FDA, Notified Body, OSHA\n* May perform direct supervision of Quality Assurance staff\n* Perform other duties as assigned by supervisor or manager\nEducation:\n* Bachelor’s Degree required in a Technical or Scientific discipline\n* Minimum 8 years of experience in a medical device design and manufacturing environment \n* Ability to apply learned technology to products and processes\n* Software proficiency: Microsoft Word, Microsoft Excel, Adobe Acrobat, LabelView\n* Strong background in FDA 21 CFR Regulations, ISO 13485, Health Canada Regulations, European Medical Device Regulations, ISO 14971\n* Possess excellent verbal and written communication skills in English. Ability to read, write and speak English in order to comprehend and execute internal Procedures, Drawings, Manufacturing Work Instructions (MWI), etc.\n* Attention to details and excellent organization skills","description_format":"text","description_chars":2737,"description_truncated":false,"requirements":{"experience_years_min":8,"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":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-11-06T05:00:54Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":3,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 2","filings_12m":2,"filings_prev_12m":1,"green_card_filings_12m":0,"median_offered_wage_usd":227500,"route":null,"cap_exempt":false,"checked_at":"2026-11-07T07:57:00+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","Alion: sponsorship offered in the employer's own job adverts (24 months)"],"filings_for_role_12m":0}],"liveness":{"score":14,"band":"cold","label":"Long shot","p_open":1,"p_active":0.315,"p_room":0.45,"age_days":26,"expected_fill_days":15,"reasons":["conf:3","agency","stale_co","velocity","win:tail","comp:brand"],"computed_at":"2026-11-07T05:47:08Z"},"pay":null,"html_url":"https://alion.io/job/planet-pharma-sr-quality-engineer-3","json_url":"https://alion.io/job/planet-pharma-sr-quality-engineer-3.json","meta":{"generated_at":"2026-11-08T02:08:23Z","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":4637,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-09T00:00:00Z"}},"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":4467183},"rest":"https://alion.io/mcp/rest/get_company?id=4467183"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fplanet-pharma-sr-quality-engineer-3"},{"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%2Fplanet-pharma-sr-quality-engineer-3"},{"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%2Fplanet-pharma-sr-quality-engineer-3"},{"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/planet-pharma-sr-quality-engineer-3\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fplanet-pharma-sr-quality-engineer-3"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3853593}},{"tool":"search_jobs","arguments":{"company":"planet-pharma.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3853593},"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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