Quality Systems & Document Control Specialist

The Davis Companies; Burlington (MA); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

On-site role

Bonus potential 15%

Direct hire

Job summary

The Davis Companies in Massachusetts, Burlington, is seeking a motivated Document Control & Quality Systems Coordinator to join our manufacturing quality team. You will manage controlled documents, coordinate corrective actions, support internal and external audits, and ensure ISO 9001 (ISO 13485 preferred) compliance.

This on-site role offers a clear path for growth in a fast‑paced industrial environment with strong emphasis on precision and traceability.

Qualifications

• 3+ years in Quality Systems, Document Control, or Quality Assurance.
• Experience with supplier/internal corrective actions.
• Hands-on involvement in internal audits.
• Working knowledge of calibration programs.
• Strong understanding of ISO 9001 (ISO 13485 preferred).
• Manufacturing experience.
• Exceptional organizational and documentation skills.

Responsibilities

• Quality Systems — Maintain controlled documents (SOPs, work instructions, specs, forms) and manage revisions, change requests, and approvals.
• Document Control — Ensure airtight retention, archival, and training record accuracy.
• Corrective Actions — Track supplier/internal CARs & SCARs, drive closure, and support root‑cause investigations.
• Audit Support — Participate in internal audits and help prepare for external and customer audits.
• ISO Compliance — Support ongoing compliance with ISO 9001; ISO 13485 experience is a strong plus.
• Calibration Programs — Coordinate calibration schedules and maintain audit‑ready equipment records.
• SAP Quality Processes — Manage quality records, workflows, and reporting through SAP.
• Continuous Improvement — Contribute to quality KPIs and process optimization initiatives.

Skills

Quality Systems

Document Control

Quality Assurance

Corrective Actions

Internal Audits

Calibration Programs

ISO 9001

ISO 13485

Manufacturing Experience

Documentation Skills

Tools

SAP

Job description

The Davis Companies in Massachusetts, Burlington, is seeking a motivated Document Control & Quality Systems Coordinator to join our manufacturing quality team. You will manage controlled documents, coordinate corrective actions, support internal and external audits, and ensure ISO 9001 (ISO 13485 preferred) compliance.

This on-site role offers a clear path for growth in a fast‑paced industrial environment with strong emphasis on precision and traceability.