{"id":129271,"date":"2026-07-15T13:30:26","date_gmt":"2026-07-15T13:30:26","guid":{"rendered":"https:\/\/bhsg.com\/jobs\/job\/p1466521bosjb_1784122226-quality-management-system-coordinator-farmington-connecticut\/"},"modified":"2026-07-15T15:48:56","modified_gmt":"2026-07-15T15:48:56","slug":"p1466521bosjb_1784122226-quality-management-system-coordinator-farmington-connecticut","status":"publish","type":"job_listing","link":"https:\/\/bhsg.com\/jobs\/job\/p1466521bosjb_1784122226-quality-management-system-coordinator-farmington-connecticut\/","title":{"rendered":"Quality Management System Coordinator"},"content":{"rendered":"<h4><strong><a id=\"myCustomID\" href=\"https:\/\/jobs.beaconhillstaffing.com\/jobs\/job\/P1466521BOSJB_1784122226\">To Apply for this Job Click Here<\/a><\/strong><\/h4>\n<p>The Quality Management System (QMS) Coordinator is responsible for the administration, maintenance, and continuous improvement of the company&#8217;s Quality Management System in compliance with applicable regulatory requirements governing microneedle manufacturing. This role serves as a central resource for document control, audit coordination, CAPA management, training compliance, and quality system metrics, ensuring that all processes conform to FDA 21 CFR Part 210\/211, 820, ISO 13485, and ICH Q10 standards.<\/p>\n<\/p>\n<p>The ideal candidate combines a strong understanding of medical device or pharmaceutical QMS principles with exceptional organizational skills and the ability to collaborate cross-functionally across manufacturing, R&amp;D, regulatory affairs, and operations teams.<\/p>\n<p> <\/p>\n<p>Responsibilities<\/p>\n<p> <\/p>\n<p><strong>Document Control &amp; Records Management<\/strong><\/p>\n<ul>\n<li>Administer and maintain the electronic document management system (EDMS), including creation, revision, approval, and archival of SOPs, work instructions, specifications, and controlled forms.<\/li>\n<li>Ensure all controlled documents are current, accurately distributed, and accessible to relevant personnel.<\/li>\n<li>Manage periodic document review schedules and track overdue reviews to closure.<\/li>\n<li>Maintain compliance with 21 CFR Part 11 requirements for electronic records and signatures.<\/li>\n<\/ul>\n<p><strong>CAPA &amp; Deviation Management<\/strong><\/p>\n<ul>\n<li>Coordinate the end-to-end Corrective and Preventive Action (CAPA) process, including initiation, root cause analysis facilitation, effectiveness verification, and closure.<\/li>\n<li>Track and trend deviations, nonconformances, complaints, and out-of-specification (OOS) events; prepare periodic quality metrics reports for management review.<\/li>\n<li>Partner with cross-functional teams to ensure timely and compliant CAPA implementation.<\/li>\n<li>Support root cause analysis using structured methodologies (e.g., Fishbone, 5 Whys, Fault Tree Analysis).<\/li>\n<\/ul>\n<p><strong>Internal &amp; External Audit Support<\/strong><\/p>\n<ul>\n<li>Coordinate and support internal quality audits, including scheduling, audit checklist preparation, observation tracking, and audit report issuance.<\/li>\n<li>Serve as a primary liaison during regulatory inspections and customer audits; manage audit readiness activities.<\/li>\n<li>Track audit findings and verify corrective actions are completed on time and effectively.<\/li>\n<li>Maintain audit program documentation and metrics in accordance with ISO 13485.<\/li>\n<\/ul>\n<p><strong>Training Program Administration<\/strong><\/p>\n<ul>\n<li>Administer the quality training program, including tracking training assignments, completions, and qualification records in the Learning Management System (LMS).<\/li>\n<li>Coordinate training for new QMS documents, regulatory updates, and process changes.<\/li>\n<li>Identify and escalate training gaps to department managers and QA leadership.<\/li>\n<\/ul>\n<p><strong>Supplier Quality Management<\/strong><\/p>\n<ul>\n<li>Assist in the qualification and ongoing monitoring of raw material suppliers and contract manufacturers, including review of Certificates of Analysis (COAs) and supplier audit schedules.<\/li>\n<li>Maintain the Approved Supplier List (ASL) and supplier quality agreements.<\/li>\n<li>Support supplier changes &amp; notifications and impact risk assessments on the QMS.<\/li>\n<\/ul>\n<p><strong>Management Review &amp; Quality Metrics<\/strong><\/p>\n<ul>\n<li>Compile, analyze, and present quality KPIs and trend data for management review meetings.<\/li>\n<li>Maintain and update the Quality Manual and quality system procedures in alignment with strategic quality objectives.<\/li>\n<li>Support continuous improvement initiatives through lean quality tools and data-driven decision making.<\/li>\n<\/ul>\n<p><strong>Operational-Specific Quality Activities<\/strong><\/p>\n<ul>\n<li>Support process validation (IQ\/OQ\/PQ) activities for microneedle fabrication processes and support execution of qualification of validation documentation and tracking.<\/li>\n<li>Assist in maintaining biocompatibility, sterility assurance, and dimensional inspection records in compliance with ISO 10993 and relevant ASTM standards.<\/li>\n<li>Coordinate review of batch records, in-process test data, and traceability of final release documentation for finished products.<\/li>\n<\/ul>\n<p><strong> <\/strong><\/p>\n<p><strong> <\/strong><\/p>\n<p><strong>QUALIFICATIONS<\/strong><\/p>\n<p><strong>Required Education &amp; Experience<\/strong><\/p>\n<ul>\n<li>Bachelor&#8217;s degree in Life Sciences, Engineering, Chemistry, Pharmaceutical Sciences, or a related field.<\/li>\n<li>Minimum 3-5+ years of QMS experience in a regulated medical device, pharmaceutical, or combination product manufacturing environment.<\/li>\n<li>Demonstrated experience with document control systems, CAPA management, internal audit and training programs.<\/li>\n<li>Working knowledge of FDA 21 CFR Part 210\/211 and 820 (Quality System Regulation \/ QSR) and ISO 13485.<\/li>\n<\/ul>\n<p><strong>Preferred Qualifications<\/strong><\/p>\n<ul>\n<li>ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) designation.<\/li>\n<li>Experience with Master Control, Veeva Vault, Trackwise or equivalent EDMS\/QMS software platforms.<\/li>\n<li>Knowledge of process validation principles (ASTM E2500, FDA Process Validation Guidance 2011).<\/li>\n<\/ul>\n<p><strong> <\/strong><\/p>\n<p><strong>SKILLS &amp; COMPETENCIES<\/strong><\/p>\n<ul>\n<li>Exceptional attention to detail and organizational skills with the ability to manage multiple priorities simultaneously.<\/li>\n<li>Strong written and verbal communication skills; ability to author and revise technical documents clearly.<\/li>\n<li>Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and quality data trending tools.<\/li>\n<li>Collaborative mindset with the ability to influence cross-functional teams without direct authority.<\/li>\n<li>Proactive problem-solving approach with a commitment to quality culture and continuous improvement.<\/li>\n<li>Ability to maintain composure and effectiveness during regulatory inspections and audits.<\/li>\n<\/ul>\n<p> <\/p>\n<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/counter.adcourier.com\/Ym9zcC41NzYxNC4xMjU4NEBiZWFjb25oaWxsLmFwbGl0cmFrLmNvbQ.gif\"><\/p>\n<p><span style=\"color: #ffffff;\">P1466521BOSJB_1784122226<\/span><\/p>\n<h4><strong><a id=\"otherId\" href=\"https:\/\/jobs.beaconhillstaffing.com\/jobs\/job\/P1466521BOSJB_1784122226\">To Apply for this Job Click Here<\/a><\/strong><\/h4>\n","protected":false},"author":0,"featured_media":3770,"template":"","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","inline_featured_image":false,"_promoted":"","_job_location":"Farmington, Connecticut","_application":"bosp.57614.12584@beaconhill.aplitrak.com","_company_name":"Beacon Hill Staffing Group","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job-categories":[213,320],"job-types":[2,16],"class_list":["post-129271","job_listing","type-job_listing","status-publish","has-post-thumbnail","hentry","job-type-full-time","job-type-temporary-contract"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Quality Management System Coordinator Farmington Connecticut<\/title>\n<meta name=\"description\" content=\"Quality Management System Coordinator Farmington Connecticut - Apply with Beacon Hill Staffing Services for this Quality Management System Coordinator job in Farmington, Connecticut\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/bhsg.com\/jobs\/job\/p1466521bosjb_1784122226-quality-management-system-coordinator-farmington-connecticut\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Quality Management System Coordinator Farmington Connecticut\" \/>\n<meta property=\"og:description\" content=\"Quality Management System Coordinator Farmington Connecticut - Apply with Beacon Hill Staffing Services for this Quality Management System Coordinator job in Farmington, Connecticut\" \/>\n<meta property=\"og:url\" content=\"https:\/\/bhsg.com\/jobs\/job\/p1466521bosjb_1784122226-quality-management-system-coordinator-farmington-connecticut\/\" \/>\n<meta property=\"og:site_name\" content=\"Nationwide Staffing Agency | Temp &amp; 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