This job is posted on behalf of Blake Smith Staffing, LLC by Top Echelon.
Quality Systems & Compliance Coordinator (Medical Device / Regulated Manufacturing)
Position Summary
We are seeking a Quality Systems & Compliance Coordinator to support and strengthen our Quality Management System (QMS) within a regulated manufacturing environment. This role is responsible for maintaining quality system processes including document control, training records, corrective and preventive actions (CAPA), nonconformance management, change control, audit readiness, supplier quality support, and risk management activities.
The ideal candidate will be highly organized, detail-oriented, and comfortable working cross-functionally to ensure compliance with internal procedures and applicable industry standards. This position plays a key role in monitoring quality system performance, driving closure of quality records, and supporting continuous improvement initiatives.
Key Responsibilities
Quality Management System Administration
- Maintain and continuously improve Quality Management System (QMS) processes and records.
- Administer electronic and paper-based quality documentation, ensuring accuracy, completeness, and compliance.
- Manage document control activities including creation, revision, approval workflows, distribution, and archival.
- Ensure employee training records remain current and aligned with controlled documentation.
CAPA & Nonconformance Management
- Coordinate and track Corrective and Preventive Actions (CAPAs), nonconformances, deviations, and investigations.
- Partner with process owners to ensure timely completion of action items and effectiveness reviews.
- Collect and maintain objective evidence supporting closure activities.
- Monitor aging reports and escalate overdue items when necessary.
Compliance Reporting & Metrics
- Generate and distribute routine quality metrics and performance reports.
- Analyze trends related to CAPAs, nonconformances, audit findings, supplier performance, training compliance, and document control effectiveness.
- Provide recommendations for process improvements based on data analysis.
Electronic QMS Management
- Support implementation, enhancement, and ongoing administration of electronic Quality Management Systems (eQMS).
- Assist with data migration, workflow standardization, user support, and process optimization.
- Ensure quality records are maintained within the designated system of record.
Audit Support
- Support internal audits, supplier audits, customer audits, and regulatory inspections.
- Maintain audit readiness documentation and evidence repositories.
- Assist with audit preparation, findings management, response development, and follow-up activities.
Continuous Improvement
- Participate in cross-functional projects focused on improving compliance, quality performance, and operational efficiency.
- Identify recurring issues and support root cause analysis efforts.
- Contribute to process improvements that reduce cycle times and strengthen product quality and regulatory compliance.
Additional Responsibilities
- Support supplier quality activities as required.
- Assist with risk management and change control initiatives.
- Perform other related duties as assigned.
Qualifications
Education
- Bachelor’s degree in Engineering, Life Sciences, Quality, Business, or a related field preferred.
- Equivalent combination of education and relevant experience will be considered.
Experience
- 1-3+ years of experience supporting quality systems, compliance, document control, or regulated operations.
- Experience working within a regulated manufacturing environment preferred.
- Familiarity with ISO-regulated quality management systems is highly desirable.
- Experience with electronic Quality Management Systems (eQMS) is a plus.
Desired Skills
Technical Skills
- Strong working knowledge of Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).
- Experience using quality management software or document management systems.
- Ability to analyze quality data and generate meaningful performance metrics.
- Understanding of CAPA, nonconformance management, document control, training management, and audit processes.
Professional Skills
- Excellent organizational and project coordination abilities.
- Strong written and verbal communication skills.
- Ability to manage multiple priorities and meet deadlines.
- High attention to detail and commitment to data accuracy.
- Collaborative team player with a continuous improvement mindset.
Core Competencies
- Quality & Compliance Orientation
- Accountability & Execution
- Analytical Problem Solving
- Communication & Relationship Building
- Continuous Improvement
- Integrity & Professional Ethics
- Collaboration & Teamwork
- Results-Driven Mindset
Work Environment
- Primarily office-based or remote work environment.
- Standard business hours with occasional flexibility needed to support business priorities.
- Limited travel may be required for audits, training, or business meetings.