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.
