{"id":2945036,"url":"https://alion.io/job/cardioquip-manufacturing-quality-specialist","title":"Manufacturing Quality Specialist","company":{"id":696035,"name":"CardioQuip","domain":"cardioquip.com","url":"https://alion.io/company/cardioquip","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Breezy","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["College Station, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":49000,"max_usd":89000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4343},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"ISO 13485","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-20T14:53:49Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-11-06T16:11:40Z","board_verified":true,"closed_at":null,"days_open":17,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":17},"description":"CardioQuip is a dynamic and innovative company specializing in the manufacturing, maintenance, and design of Cardiovascular Operating room technology. We are seeking a motivated Manufacturing Quality Specialist to join our team. This position plays a crucial role in ensuring the functionality and reliability of our products, which are vital for medical applications.\nDirect Report: Director of Manufacturing\nWorks regularly with Production, Document Control, and the Director of Quality and Regulatory.\nResponsibilities\nOriginates and investigates manufacturing nonconformances per applicable procedures;ensures nonconforming material is properly identified, quarantined, and controlled.\n\nRepresents Manufacturing on the Material Review Board (MRB), as appointed; supportsdispositions, defect coding, trending, and escalation to CAPA or SCAR, as appropriate.\n\nOwns manufacturing CAPAs as assigned, from initiation through closure, including rootcause investigation, action planning, implementation, and verification of effectiveness.\n\nAuthors and revises manufacturing and supply chain SOPs and assists with updates to workand assembly instructions through the change order process.\n\nGenerates, reviews, and uploads Device History Record (OHR) documentation for eachdevice built, in accordance with applicable procedures, ensuring complete traceability.\n\nPerforms OHR reviews to verify that production documentation is complete, accurate, andappropriately executed prior to final release.\n\nSupports receiving inspection dispositions, supplier evaluations, SCAR issuance andtracking, and CAPA-related communication with suppliers and contract manufacturers.\n\nAssists the Quality Inspector with inspections on the manufacturing floor, as needed.\nSupports internal audits and FDA/notified body inspections of manufacturing and supplychain areas and prepares production quality metrics for management review.\n\nPerforms other duties as assigned.\nRequired Skills/Abilities\nReads and interprets technical drawings, bills of material, and assembly instructions.\nApplies good documentation practices (GDP) and structured root cause analysis methods.\nProficient with Microsoft Office Suite.\nStrong attention to detail, sound judgment, and clear communication with production teams.\nEducation and Experience\nTwo years of manufacturing or quality experience required; medical device experience preferred.\n Associate or Bachelor's degree in a technical or quality discipline preferred.\n Knowledge of ISO 13485:2016, 21 CFR 820 (QMSR), and EU MOR 2017/745 preferred.\n Hands-on experience with nonconformance, CAPA, and OHR processes strongly preferred.\n Experience with ERP and electronic document control systems preferred.\n ASQ CQA, CQE, or CQT certification preferred.\nPhysical Requirements\nMust be able to traverse the distribution warehouse and access a variety of storage spaces and shelving units by stretching, squatting, and reaching.\nMust be able to lift up to 50 pounds at a time.\nWhat We Offer\nCompetitive CompensationA fair salary commensurate with experience and qualifications.\n\nComprehensive BenefitsHealth, dental, and vision insurance.\nRetirement savings plan with company contribution.\n\nDynamic Work EnvironmentA supportive team culture that values innovation, improvement, and empowerment.\n\nWork-Life BalancePaid time off, including vacation days and holidays.\n\nFun and Engaging CultureWe believe in working hard and celebrating our successes together, fostering a sense of camaraderie and enjoyment in our work.\n\nWhy Join?\nAt CardioQuip, we are dedicated to empowering people towards better healthcare. As a leading company in the medical device industry, we design and manufacture advanced cardiovascular devices that make a real difference in patients' lives. Our humble beginnings started with just two founders in a small office, and we've grown into a dynamic team that values every member's contribution. We believe in fostering an environment where our team is empowered, customer-focused, and continually striving for improvement-all while having fun along the way.","description_format":"text","description_chars":4082,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Retirement plans","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Health & Medical Electronics"],"lifecycle":[{"event":"open","at":"2026-10-20T18:32:38Z"}],"visa":[],"liveness":{"score":71,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.79,"p_room":0.9,"age_days":16,"expected_fill_days":28,"reasons":["conf:2","win:mid","comp:junior"],"computed_at":"2026-11-06T05:58:05Z"},"pay":null,"html_url":"https://alion.io/job/cardioquip-manufacturing-quality-specialist","json_url":"https://alion.io/job/cardioquip-manufacturing-quality-specialist.json","meta":{"generated_at":"2026-11-06T19:24:35Z","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":2668,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"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":696035},"rest":"https://alion.io/mcp/rest/get_company?id=696035"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcardioquip-manufacturing-quality-specialist"},{"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%2Fcardioquip-manufacturing-quality-specialist"},{"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%2Fcardioquip-manufacturing-quality-specialist"},{"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/cardioquip-manufacturing-quality-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcardioquip-manufacturing-quality-specialist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2945036}},{"tool":"search_jobs","arguments":{"company":"cardioquip.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2945036},"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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