{"id":3118566,"url":"https://alion.io/job/arch-medical-solutions-document-control-coordinator","title":"Document Control Coordinator","company":{"id":3872572,"name":"ARCH Medical Solutions","domain":"arch-medical.com","url":"https://alion.io/company/arch-medical","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"UltiPro","truth_index":{"grade":"B","score":75,"open_postings":7,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":26,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Administrative","role_family":"Administrative","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":["Elmhurst, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":26,"max":30,"currency":"USD","period":"hour","gross":null,"usd_annual":60000},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-10-22T21:18:23Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-25T13:25:01Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Primary Responsibilities\nMaintains, updates and manages QCBD (Quality Collaboration By Design) document file system.\nOrganizes and oversees QCBD training related to the Quality Management system.\nExecutes document approval, release, archival, and obsolescence, per the quality system.\nModifies and documents changes to Quality System Procedures.\nFunctions as an information source for production, and other departments when critical quality documentation issues arise.\nSubmits and processes change orders under ISO 13485 and FDA 21 CFR Part 820.\nMonitors device history records process to meet ISO 13485 and FDA 21 CFR Part 820.\nPerforms device history record review.\nMay perform data entry and trend analysis and initiate negative trend corrective actions.\nWorks with management in all company areas to effectively resolve document errors/omissions.\nUpdates and maintains product DMR’s.\nMaintains staff training records and working with supervision ensuring that all QCBD training is to current requirements.\nAccurately enters data into EPICOR.\nProvides document support for internal and external audits, as needed.\nMay educate and instruct plant personnel in recommended quality control testing and equipment methods and acceptable documentation practices.\nAssists other departments with ad-hoc projects and serves as a back up per business needs.\nOther duties as assigned.\nQualifications\nAssociate degree in applicable technical discipline is strongly preferred or equivalent,\nor two (2) to three (3) years of experience in medical device manufacturing industry and/or document management systems and/or training,\nor equivalent combination of education and experience.\nBasic regulatory knowledge in medical regulations.\nAccuracy of typing skills and extreme attention to detail are required.\nKnowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations.\nShifts Available: 1st shift\nSalary Range: $26.00 - $30.00/hr based on experience\nEqual Employer Opportunity\nARCH is an Equal Opportunity Employer who wholeheartedly supports diversity in the workplace as basic premise for business success. We do not discriminate on a basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. 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