Document Control Specialist - Direct Hire

Job Description

Job Description

Document Control Specialist

Norristown, PA (On-Site)
$85,000 - $95,000 Annual Salary
Schedule: Tuesday - Friday | 7:00 AM - 5:30 PM

About the Opportunity

We're partnering with a growing medical device manufacturer seeking a detail-oriented Document Control Specialist to support its Quality Management System (QMS) and document control processes. This position plays a critical role in maintaining compliance, controlling documentation, supporting quality initiatives, and ensuring the integrity of records within a regulated manufacturing environment.

This is an excellent opportunity for a professional with experience in ISO 13485 and/or ISO 9001 environments who enjoys working cross-functionally with Quality, Manufacturing, Engineering, and Operations teams.

Key Responsibilities

• Manage the full lifecycle of controlled documents, including revisions, approvals, releases, and version control.
• Process and coordinate document change requests, change orders, and document review workflows.
• Maintain electronic and paper-based document control systems and quality records.
• Support Quality Management System (QMS) activities including CAPAs, nonconformance records (NCRs), inspections, and audit readiness.
• Prepare, maintain, and control Device History Records (DHRs), Device Master Records (DMRs), SOPs, work instructions, and training records.
• Ensure documentation is accurate, compliant, and aligned with regulatory and internal quality requirements.
• Track training requirements and maintain employee training documentation.
• Generate quality and compliance reports and support continuous improvement initiatives.

Qualifications

• 3+ years of experience in Document Control, Quality Systems, Compliance, or a related field.
• Experience working within an ISO 13485 and/or ISO 9001 environment is required.
• Knowledge of Quality Management Systems (QMS), document control processes, and change management procedures.
• Experience supporting CAPA, NCR, audit, or regulated manufacturing activities preferred.
• Strong organizational skills and exceptional attention to detail.
• Proficiency with Microsoft Office and electronic document management systems.
• Bachelor's degree or equivalent work experience preferred.

Why Consider This Opportunity?

• Competitive salary of $85,000 - $95,000
• Unique 4-day work week (Tuesday-Friday)
• Opportunity to work in a highly regulated medical device manufacturing environment
• High-impact role supporting quality, compliance, and operational excellence
• Stable organization with opportunities to contribute across multiple functions

Apply today if you have document control or quality systems experience in an ISO-regulated environment and are looking for a challenging, rewarding opportunity in the medical device industry.

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