{"id":478021,"url":"https://alion.io/job/omnicell-sr-quality-engineer","title":"Sr. Quality Engineer","company":{"id":176630,"name":"Omnicell","domain":"omnicell.com","url":"https://alion.io/company/omnicell","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Eightfold","truth_index":{"grade":"B","score":78,"open_postings":10,"ghost_share":0,"stale_share":0.9,"repost_share":0,"time_to_fill_p50_days":34,"computed_at":"2026-09-30T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cranberry Township, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":95000,"max_usd":182000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2941},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-20T16:16:25Z","employer_posted_date":"2026-08-24","last_verified_at":"2026-09-30T08:25:59Z","board_verified":true,"closed_at":null,"days_open":41,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":41},"description":"Responsibilities:\nChange Control and Design:\nLead the execution of defect management and engineering escalation processes, ensuring timely identification, resolution, and reporting of product issues.\nDrive the review and approval of design and service verification and validation protocols, with a focus on product changes and lifecycle processes.\nManage cross-functional teams in product change control processes and ensure comprehensive documentation of product modifications.\nTake ownership of maintaining and updating the Device Master Record (DMR) for assigned product lines during post-market changes.\nEnsure alignment of design outputs with inputs, proactively addressing discrepancies and ensuring compliance with internal protocols.\nAct as the lead liaison between engineering, product management, and quality teams to integrate quality considerations early in the product design phase.\nField, Customer and Safety:\nIndependently process and triage out-of-box quality issues, conducting root cause analyses and collaborating with teams to drive corrective actions.\nLead post-production safety risk assessments and implement solutions to mitigate safety concerns.\nDrive the Medical Device Reporting (MDR) process, coordinating with regulatory bodies and managing field actions and recalls.\nPresent safety and risk management updates during Safety Risk Management Board Meetings, with responsibility for product-specific risks.\nCompliance and Continuous Improvement:\nLead quality improvement projects aimed at optimizing processes, reducing defects, and enhancing customer satisfaction.\nEnsure adherence to ISO 9001, ISO 13485, and other relevant regulatory standards, acting as a subject matter expert for compliance.\nImplement and analyze quality metrics, creating reports to monitor process performance and drive data-driven improvements.\nConduct internal audits and manage corrective and preventive actions (CAPA) to ensure continued compliance and improvement.\nRequired Knowledge and Skills:\nAdvanced knowledge of QMS (Quality Management System) documentation and regulatory standards (ISO 9001, ISO 13485).\nProficiency in quality investigation tools (e.g., Fishbone diagrams, 5 Whys) and statistical analysis (e.g., SPC, Six Sigma).\nUnderstanding of software development lifecycle (SDLC) and experience in defect tracking platforms like Jira\nExperience in leading cross-functional teams and managing product changes from initiation through post-market stages.\nStrong project management skills and the ability to manage multiple priorities effectively.\nExcellent problem-solving, communication, and leadership abilities.\nBasic Qualifications:\n\nBachelor’s degree in Engineering or Science discipline\n5+ years in Engineering, Quality or related technical professional experience\nExperience in product development and/or maintenance \nExperience in process development \nExperience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA QMSR) \nPreferred Qualifications:\nExperience working with complex electro-mechanical systems\nExperience working with Cloud software and AI/ML\nWork Conditions:\nOffice Environment\nMay travel up to 25%\nBase Compensation: $80,000.00 to $115,000.00\n(Actual compensation is subject to variation due to such factors as location, education, experience, and skillset. We offer a comprehensive benefits package, including medical, dental and vision plans covering eligible US employees and dependents, voluntary wellness and employee assistance programs, life insurance, disability, retirement plans with matching, and paid time off.)","description_format":"text","description_chars":3579,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-09-06T15:29:15Z"},{"event":"open","at":"2026-09-09T02:20:00Z"},{"event":"open","at":"2026-09-20T03:00:00Z"}],"liveness":{"score":30,"band":"fade","label":"Fading","p_open":1,"p_active":0.547,"p_room":0.55,"age_days":40,"expected_fill_days":34,"reasons":["conf:28","stale_co","velocity","win:tail"],"computed_at":"2026-09-30T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/omnicell-sr-quality-engineer","json_url":"https://alion.io/job/omnicell-sr-quality-engineer.json","meta":{"generated_at":"2026-10-01T03:37:54Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":3179,"day_limit":5000,"remaining_today":1821,"minute_limit":60,"resets_at":"2026-10-02T00:00:00Z"}}}