{"id":3932878,"url":"https://alion.io/job/modular-medical-quality-engineer","title":"Quality Engineer","company":{"id":4472997,"name":"Modular Medical","domain":"modularmedical.com","url":"https://alion.io/company/modular-medical","size_band":"201-500","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":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":80000,"max":130000,"currency":"USD","period":"year","gross":null,"usd_annual":130000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design of Experiments","optional":false},{"name":"ISO 13485","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-09-11T02:35:00Z","employer_posted_date":"2026-09-11","last_verified_at":"2026-11-08T03:32:25Z","board_verified":true,"closed_at":null,"days_open":58,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":58},"description":"The Quality Engineer will be a key member of Modular Medical’s Quality team, collaborating with other team members to ensure compliance with the Quality System Regulations, ISO 13485, and any additional relevant regulations. The role is responsible for maintaining a strong collaborative partnership across various functions within the organization. The Quality Engineer will act as a Quality representative, enhancing awareness, visibility, and communication regarding all quality initiatives to support departmental, functional, and company-wide quality goals and priorities. Effective communication with all levels of the organization is essential.\nRole and Responsibilities\nDevelop data analysis and trending processes for quality metrics, including establishing alert and action limits\nManages and drives regular review of quality metrics\nAssists in organizing and coordinating the management review process\nWorks closely with program teams to ensure timely and accurate completion of Quality deliverables\nDrives quality, reliability, and compliance with standards and regulations\nConducts nonconformance and complaint investigations, including proper documentation and timely completion\nActs as the CAPA coordinator \nResponsible for ensuring proper processes and procedures are followed, driving improvements to maintain compliance and enhance efficiency.\nSupport both internal & external audits, including front/back room support and audit responses.\nComplies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.\nExercise good judgment in planning and organizing work; monitors performance and reports status.\nMaintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.\nPerforms other related duties and responsibilities, when necessary.\nQualifications and Education Requirements\nBS degree in engineering, data science, technical or scientific discipline; and/or equivalent combination of education and experience.\nMinimum 3-5 years' experience in the FDA regulated environment, preferably associated with medical devices.\nWork under minimal supervision. Relies on experience and good judgment to plan and accomplish assigned goals. \nMay periodically assist in orienting, training, and/or reviewing the work of peers.\nExperience with statistical analysis and trending of data\nExperience with quality systems and standards compliance\nFamiliarity with FDA/ ISO and IEC standards and regulations\nExcellent verbal and written analytical/problem-solving, communication, negotiation, interpersonal and presentation skills\nAdvanced personal computing skills, including report writing, and familiarity with common MS Office applications\nAbility to work within a team and as an individual contributor in a fast-paced, changing environment\nAbility to leverage and/or engage others to accomplish projects.\nMultitasks, prioritizes and meets deadlines in timely manner.\nStrong organizational and follow-up skills, as well as attention to detail.\nAbility to maintain regular and predictable attendance\nPreferred\nExperience with statistical methods (e.g. statistical process control, sampling plans, gauge R&R, and design of experiments)\nExperience setting up and utilizing software platforms designed for measuring big data.\nRoot cause analysis experience\nExperience in the diabetes space","description_format":"text","description_chars":3465,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Health & Medical Electronics","Diabetes Devices"],"lifecycle":[{"event":"open","at":"2026-11-08T03:32:25Z"}],"visa":[],"liveness":{"score":26,"band":"fade","label":"Fading","p_open":1,"p_active":0.582,"p_room":0.45,"age_days":58,"expected_fill_days":30,"reasons":["conf:2","win:tail"],"computed_at":"2026-11-08T05:47:12Z"},"pay":{"stated_usd_annual":130000,"is_top_pay":true},"html_url":"https://alion.io/job/modular-medical-quality-engineer","json_url":"https://alion.io/job/modular-medical-quality-engineer.json","meta":{"generated_at":"2026-11-08T06:00:44Z","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":13041,"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":4472997},"rest":"https://alion.io/mcp/rest/get_company?id=4472997"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmodular-medical-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%2Fmodular-medical-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%2Fmodular-medical-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/modular-medical-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmodular-medical-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3932878}},{"tool":"search_jobs","arguments":{"company":"modularmedical.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3932878},"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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