{"id":1710559,"url":"https://alion.io/job/leiters-senior-quality-engineer","title":"Senior Quality Engineer","company":{"id":3799549,"name":"Leiters","domain":"leiters.com","url":"https://alion.io/company/leiters","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"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":["Englewood, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":97000,"max":140000,"currency":"USD","period":"year","gross":null,"usd_annual":140000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-09T21:45:00Z","employer_posted_date":"2026-09-09","last_verified_at":"2026-10-10T20:45:16Z","board_verified":true,"closed_at":null,"days_open":31,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":31},"description":"The Senior Quality Engineer plays a critical role in ensuring that products and processes meet the highest standards of quality and reliability. This position is responsible for leading quality assurance initiatives, developing and implementing quality control systems, and driving continuous improvement across manufacturing and development teams. The Senior Quality Engineer collaborates closely with cross-functional teams including design, production, and supply chain to identify potential quality issues and implement effective corrective actions. This role requires a strategic thinker who can analyze complex data, lead root cause investigations, and influence quality culture throughout the organization. Ultimately, the Senior Quality Engineer ensures that customer expectations are consistently met or exceeded, contributing to the company’s reputation for excellence and compliance with industry standards and regulations.\nWhy Join Leiters Health?\nAre you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further - Leiters Health is seeking talented individuals like you to join our dynamic team!\nAt Leiters Health, we're not just another pharmaceutical company - we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.\nInnovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.\nMeaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.\nProfessional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.\nCutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.\nCollaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.\nWho We're Looking For:\nWe're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!\nResponsibilities:\nProgram ownership of continued process verification (CPV)\nLead and coach teams on complex investigations; ensure statistical/technical rigor and business continuity.\nFacilitate site PFMEA reviews; institutionalize risk registers; align mitigation control strategies.\nQuality by Design (QbD): Partner with Manufacturing, Science, and Technology (MSAT) for control strategy updates and CPV enhancements; enable Product Process Qualification (PPQ) readiness where applicable.\nLead and manage continuous improvement projects focused on improving yield, Right First Time (RFT), and cycle time, from opportunity identification through implementation.\nCo-lead audit front-room topics; lead back-room coordination and commitments tracking.\nAnalyze quality data and metrics to identify trends, risks, and opportunities for continuous improvement.\nTrain and mentor junior quality engineers and other team members on quality best practices and methodologies.\nMinimum Qualifications:\nBachelor’s degree in Biomedical Engineering, Quality Management, or a related technical field.\n5+ years of experience in quality engineering or quality assurance roles within a manufacturing or product development environment.\nStrong knowledge of quality management systems (QMS) and industry standards such as ISO 9001, 21CFRPart 210 and 211.\nProficiency in root cause analysis tools and methodologies such as 8D, Fishbone diagrams, and FMEA.\nExperience with statistical process control (SPC) and data analysis software.\nPreferred Qualifications:\nCertification as ASQ CQE/CQA/CSSBB or equivalent.\nExperience working in regulated industries such as pharmaceuticals, medical devices, or aerospace.\nFamiliarity with regulatory requirements including FDA 21CFR, ISO 13485, or AS9100 standards.\nAdvanced degree in Engineering, Quality, or related discipline.\nProficiency with quality management software and ERP systems.\nExperience leading or managing continuous improvement initiatives and/or cross-functional projects.\nProject management experience or relevant certification (e.g., PMP, Lean, Six Sigma).\nBenefits:\nSmart healthcare coverage options that rewards wellness (and puts money back in your pocket!)\nFlexible Spending & Health Savings Accounts (FSA & HSA) available\nDental & Vision insurance \nEmployer Paid Life Insurance & Employee Assistance Program\nShort Term & Long-Term Disability Insurance\nUp to 4% 401K Matching (100% vested on day one!)\nGenerous Paid Time Off Options - vacation, sick, paid leave and holidays!\n$5,250 Annual Tuition Reimbursement after 6 months\n$1,000 Referral Bonus Program with no limit\nEligible for annual bonus program \nTimeline: We will be accepting applications on an ongoing basis until position is filled.\nWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.\n*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.","description_format":"text","description_chars":6106,"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":["401k plan","Growth opportunities","Life insurance","Professional development","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Hospitals & Health Systems","Process Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-02T17:11:53Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":92500,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":64,"band":"ok","label":"Likely open","p_open":1,"p_active":0.85,"p_room":0.75,"age_days":30,"expected_fill_days":40,"reasons":["conf:2","urgency","win:late"],"computed_at":"2026-10-10T05:45:15Z"},"pay":{"stated_usd_annual":140000,"is_top_pay":true},"html_url":"https://alion.io/job/leiters-senior-quality-engineer","json_url":"https://alion.io/job/leiters-senior-quality-engineer.json","meta":{"generated_at":"2026-10-11T01:31:56Z","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","counted_by":"address","units_charged":1,"used_today":2308,"day_limit":5000,"remaining_today":2692,"minute_limit":60,"resets_at":"2026-10-12T00:00:00Z"}},"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":3799549},"rest":"https://alion.io/mcp/rest/get_company?id=3799549"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fleiters-senior-quality-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%2Fleiters-senior-quality-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%2Fleiters-senior-quality-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/leiters-senior-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fleiters-senior-quality-engineer"}]}