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.