Quality Documentation & Compliance Specialist

Bright Research; Minneapolis (MN); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Parking

Health insurance

Parental leave

Disability benefits

401(k) with company match

Tuition reimbursement

12 paid holidays

On-site gym

Job summary

Bright Research, a Medical Device CRO in downtown Minneapolis, seeks a Quality Document Control Specialist to protect the integrity of our QMS. You will manage controlled documents, ensure audit trails, and support eQMS/eDMS while collaborating with cross-functional teams.

The role requires 2+ years in document control or a regulated field, familiarity with FDA QMSR/ISO 13485, and strong attention to detail and communication skills.

Qualifications

• 2+ years in document control or regulated quality function.
• Familiarity with FDA QMSR, 21 CFR Part 820 and ISO 13485 preferred.
• Excellent attention to detail and clear written communication.

Responsibilities

• Administer and maintain controlled-document and records-management processes.
• Ensure SOPs, work instructions, forms, and quality records are version controlled and auditable.
• Guide document owners through control processes and maintain training records.
• Support eQMS/eDMS platform administration and related processes.
• Assist with audits, inspections, CAPA activities, and change controls.

Skills

Document control

Regulatory affairs

Quality systems

Microsoft 365

eQMS/eDMS

Tools

eDMS

eQMS

Microsoft 365

Job description

Bright Research, a Medical Device CRO in downtown Minneapolis, seeks a Quality Document Control Specialist to protect the integrity of our QMS. You will manage controlled documents, ensure audit trails, and support eQMS/eDMS while collaborating with cross-functional teams.

The role requires 2+ years in document control or a regulated field, familiarity with FDA QMSR/ISO 13485, and strong attention to detail and communication skills.