Quality Systems Document Control Specialist

Talentify; Minneapolis (MN); On-site; USD 41,000 - 48,000; Full time

Benefits offered by this job

Medical/dental/vision

401(k) Retirement Plan

Life Insurance

Disability coverage

HSA

Job summary

Actalent is seeking a Document Control Specialist for a contract-to-hire role in Minneapolis, MN. The position focuses on managing engineering and product documentation in a regulated medical device environment, ensuring GDP and compliance with ISO, FDA 21 CFR 820, and EU MDR.

You will administer PDM/ERP data, maintain BOMs and lifecycle records, support audits, and collaborate with engineering, quality, and manufacturing to implement continuous improvements across documentation workflows.

Qualifications

• 3+ years in a medical device environment with documentation and quality system activities.
• Familiar with ISO 9001 and FDA 21 CFR Part 820 requirements.
• Experience with Engineering/Product Data Management (PDM) systems.
• GDP implementation and maintenance across documentation workflows.

Responsibilities

• Manage and maintain engineering and product documentation per ISO/FDA requirements.
• Administer PDM systems to keep records, drawings and specs current.
• Implement GDP across documentation workflows and processes.
• Maintain BOMs and master data in ERP/MRP systems.
• Review, approve, release, and archive changes per QMS procedures.
• Collaborate with engineering, quality, and manufacturing on document changes and releases.
• Support configuration management to ensure lifecycle documentation consistency.
• Track documentation status and metrics using databases and reporting tools.
• Prepare, format and edit documents using MS Word/Excel/Visio/PowerPoint.

Skills

Medical device experience

GDP knowledge

ISO 9001

FDA CFR 820

PDM/ERP systems

MS Office

Documentation control

Tools

AutoCAD

SolidWorks

Pro/ENGINEER (Pro E)

Job description

Actalent is seeking a Document Control Specialist for a contract-to-hire role in Minneapolis, MN. The position focuses on managing engineering and product documentation in a regulated medical device environment, ensuring GDP and compliance with ISO, FDA 21 CFR 820, and EU MDR.

You will administer PDM/ERP data, maintain BOMs and lifecycle records, support audits, and collaborate with engineering, quality, and manufacturing to implement continuous improvements across documentation workflows.