Document Control Specialist — 4-Day Week, ISO QMS

PeopleShare by PROMAN

Norristown (Montgomery County)

On-site

USD 85,000 - 95,000

Full time

4 days ago
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Job summary

PeopleShare by PROMAN is seeking a detail-oriented Document Control Specialist in Norristown, PA, on-site. The role supports QMS and document control, ensuring regulatory compliance and accurate records in a medical device manufacturing setting.

Requirements include 3+ years in document control or quality systems and experience with ISO 13485 or ISO 9001. The position offers $85,000-$95,000 annually and a unique four-day work week, Tuesday-Friday.

Qualifications

  • 3+ years of experience in Document Control, Quality Systems, or a related field.
  • Experience in ISO 13485 and/or ISO 9001 environments is required.
  • Knowledge of QMS, document control processes and change management.
  • Experience supporting CAPA, NCR, audits, or regulated manufacturing activities.
  • Proficiency with Microsoft Office and electronic document management systems.

Responsibilities

  • Manage full lifecycle of controlled documents including revisions, approvals, and releases.
  • Process document change requests, change orders, and review workflows.
  • Maintain electronic and paper-based document control systems and quality records.
  • Support QMS activities including CAPAs, NCRs, inspections, and audits readiness.
  • Prepare and control DHRs, DMRs, SOPs, work instructions, and training records.
  • Ensure documentation is accurate, compliant and aligned with requirements.
  • Track training requirements and maintain employee training documentation.
  • Generate quality and compliance reports and support continuous improvement.

Skills

Detail-oriented
Strong organizational skills

Education

Bachelor's degree or equivalent

Job description

PeopleShare by PROMAN is seeking a detail-oriented Document Control Specialist in Norristown, PA, on-site. The role supports QMS and document control, ensuring regulatory compliance and accurate records in a medical device manufacturing setting.

Requirements include 3+ years in document control or quality systems and experience with ISO 13485 or ISO 9001. The position offers $85,000-$95,000 annually and a unique four-day work week, Tuesday-Friday.

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