Quality Compliance & Document Control Specialist

Job Category: Manufacturing

Requisition Number: QUALI
005318

• Full-Time
• On-site

Showing 1 location

Quality Compliance & Document Control Specialist

Reports To: Quality Manager

Pay Range: $75-95,000

Position Summary

ARCH Medical Solutions is seeking a detail-oriented and proactive Quality Compliance & Document Control Specialist to support the maintenance, effectiveness, and compliance of our Quality Management System (QMS). This role combines responsibility for document control, training administration, audit readiness, regulatory compliance, quality records management, and continuous improvement initiatives within a precision machining environment serving the medical device industry.

The ideal candidate will have experience with ISO 13485, document control processes, quality systems administration, internal audits, and regulatory compliance. This individual will work closely with cross-functional teams to ensure quality documentation remains accurate, current, and compliant with customer and regulatory requirements.

Essential Duties and Responsibilities

Quality Management System (QMS)

• Maintain and continuously improve the Quality Management System in accordance with ISO 13485, FDA regulations, customer requirements, and company standards.
• Manage QMS documentation, procedures, forms, policies, and records to ensure current revision status and availability.
• Support external customer audits, surveillance audits, recertification audits, and regulatory inspections.
• Coordinate and support the Internal Audit Program.
• Assist with CAPA, customer complaint investigations, NCMRs, and corrective action activities.
• Perform quality data analysis and trend reporting related to customer complaints, scrap, quality metrics, and process performance.
• Support development and implementation of continuous improvement initiatives.
• Conduct QMS-related training and maintain training compliance records.
• Serve as a resource regarding quality policies, procedures, and regulatory requirements.

Document Control & Records Management

• Maintain control of all quality system documentation and related records.
• Ensure procedures, work instructions, SOPs, forms, and engineering documents are properly reviewed, approved, distributed, and archived.
• Manage document revision history and associated document control logs.
• Process Engineering Change Orders (ECOs) and track implementation activities.
• Create and update inspection forms, method sheets, and balloon/bubble drawings.
• Maintain Device History Records (DHRs) and quality records in accordance with customer and regulatory requirements.
• Manage approved supplier documentation and supplier quality agreements.
• Facilitate employee training on new or revised procedures and ensure training records are maintained.
• Provide administrative support including scanning, filing, labeling, printing, and record retention activities.

Compliance & Cross-Functional Support

• Assist with contract and customer requirement reviews to ensure compliance.
• Monitor and maintain quality-related KPI data and reporting.
• Collaborate with HR and department leaders to maintain training matrices and onboarding documentation.
• Support ERP system data entry and maintenance related to quality and documentation activities.
• Interface with customers and suppliers regarding quality documentation and compliance matters.
• Participate in root cause investigations and quality improvement projects.
• Perform other duties as assigned.

Qualifications

Education & Experience

• Associate degree in a technical, quality, engineering, or related field with 3+ years of relevant experience; or
• Bachelor's degree in Quality, Engineering, Life Sciences, or related discipline preferred; or
• Equivalent combination of education and experience.

• Experience in Quality Systems, Document Control, or Regulatory Compliance within a regulated manufacturing environment.
• Experience supporting ISO 13485 quality systems
• Experience with medical device manufacturing preferred.
• Experience with ERP systems, document management systems, and electronic quality records preferred.

Knowledge, Skills & Abilities

• Working knowledge of ISO 13485 and FDA Quality System Regulations.
• Strong understanding of document control processes and best practices.
• Experience conducting internal audits and supporting external audits.
• Knowledge of CAPA, complaint handling, root cause analysis, and continuous improvement methodologies.
• Proficiency in Microsoft Word, Excel, Outlook, and document…