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The Quality Management System (QMS) Coordinator is responsible for the administration, maintenance, and continuous improvement of the company’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.
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&D, regulatory affairs, and operations teams.
Responsibilities
Document Control & Records Management
- Administer and maintain the electronic document management system (EDMS), including creation, revision, approval, and archival of SOPs, work instructions, specifications, and controlled forms.
- Ensure all controlled documents are current, accurately distributed, and accessible to relevant personnel.
- Manage periodic document review schedules and track overdue reviews to closure.
- Maintain compliance with 21 CFR Part 11 requirements for electronic records and signatures.
CAPA & Deviation Management
- Coordinate the end-to-end Corrective and Preventive Action (CAPA) process, including initiation, root cause analysis facilitation, effectiveness verification, and closure.
- Track and trend deviations, nonconformances, complaints, and out-of-specification (OOS) events; prepare periodic quality metrics reports for management review.
- Partner with cross-functional teams to ensure timely and compliant CAPA implementation.
- Support root cause analysis using structured methodologies (e.g., Fishbone, 5 Whys, Fault Tree Analysis).
Internal & External Audit Support
- Coordinate and support internal quality audits, including scheduling, audit checklist preparation, observation tracking, and audit report issuance.
- Serve as a primary liaison during regulatory inspections and customer audits; manage audit readiness activities.
- Track audit findings and verify corrective actions are completed on time and effectively.
- Maintain audit program documentation and metrics in accordance with ISO 13485.
Training Program Administration
- Administer the quality training program, including tracking training assignments, completions, and qualification records in the Learning Management System (LMS).
- Coordinate training for new QMS documents, regulatory updates, and process changes.
- Identify and escalate training gaps to department managers and QA leadership.
Supplier Quality Management
- 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.
- Maintain the Approved Supplier List (ASL) and supplier quality agreements.
- Support supplier changes & notifications and impact risk assessments on the QMS.
Management Review & Quality Metrics
- Compile, analyze, and present quality KPIs and trend data for management review meetings.
- Maintain and update the Quality Manual and quality system procedures in alignment with strategic quality objectives.
- Support continuous improvement initiatives through lean quality tools and data-driven decision making.
Operational-Specific Quality Activities
- Support process validation (IQ/OQ/PQ) activities for microneedle fabrication processes and support execution of qualification of validation documentation and tracking.
- Assist in maintaining biocompatibility, sterility assurance, and dimensional inspection records in compliance with ISO 10993 and relevant ASTM standards.
- Coordinate review of batch records, in-process test data, and traceability of final release documentation for finished products.
QUALIFICATIONS
Required Education & Experience
- Bachelor’s degree in Life Sciences, Engineering, Chemistry, Pharmaceutical Sciences, or a related field.
- Minimum 3-5+ years of QMS experience in a regulated medical device, pharmaceutical, or combination product manufacturing environment.
- Demonstrated experience with document control systems, CAPA management, internal audit and training programs.
- Working knowledge of FDA 21 CFR Part 210/211 and 820 (Quality System Regulation / QSR) and ISO 13485.
Preferred Qualifications
- ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) designation.
- Experience with Master Control, Veeva Vault, Trackwise or equivalent EDMS/QMS software platforms.
- Knowledge of process validation principles (ASTM E2500, FDA Process Validation Guidance 2011).
SKILLS & COMPETENCIES
- Exceptional attention to detail and organizational skills with the ability to manage multiple priorities simultaneously.
- Strong written and verbal communication skills; ability to author and revise technical documents clearly.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and quality data trending tools.
- Collaborative mindset with the ability to influence cross-functional teams without direct authority.
- Proactive problem-solving approach with a commitment to quality culture and continuous improvement.
- Ability to maintain composure and effectiveness during regulatory inspections and audits.
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