Quality Document Control 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 is a dynamic and growing Medical Device Clinical Research Organization (CRO) based in downtown Minneapolis. We expertly manage clinical trials from concept to completion, leveraging our expertise to simplify complex challenges. As we continue to grow, we are seeking aQuality Document Control Specialist to support our Quality Management System and ensure document integrity, compliance, and operational excellence.

What Will Help You Thrive

This role is ideal for someone who enjoys creating structure, accuracy, and compliance within regulated processes. Successful candidates are highly organized, detail-oriented, collaborative, and committed to maintaining quality standards across the document lifecycle.

What You'll Do

• Administer and maintain controlled-document and records-management processes, including document creation, review, approval, issuance, revision, distribution, retention, archival, and obsolescence activities.
• Ensure SOPs, work instructions, forms, and quality records are maintained through version control, metadata management, approval workflows, and audit trails.
• Guide document owners through document control processes, provide training, and maintain training assignments and completion records.
• Support the administration and continuous improvement of eQMS and eDMS platforms and related document-management processes.
• Prepare document control, training, and quality metrics and support audits, inspections, CAPA activities, and change controls.

What You'll Bring

• 2+ years of experience in document control, quality systems, regulatory affairs, manufacturing, or a related function in a regulated industry.
• Strong understanding of document lifecycle management, change control, records retention, and archival requirements.
• Experience working with electronic document management or quality systems and Microsoft 365 applications.
• Knowledge of FDA QMSR, 21 CFR Part 820, ISO 13485, and applicable quality and regulatory requirements preferred.
• Exceptional attention to detail, organizational skills, and written communication abilities.

Complimentary paid parking, comprehensive health insurance (medical, dental, and vision), paid parental leave, short- and long-term disability benefits, a 401(k) with company match, tuition reimbursement, at least 12 paid company holidays, and access to an on-site gym.

Bright Research is an Equal Opportunity Employer and is committed to building an inclusive workplace where all employees can thrive. We celebrate diversity and are committed to creating an environment in which all applicants and employees are treated with respect and provided equal employment opportunities regardless of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, genetic information, or any other characteristic protected by applicable federal, state, or local law.

Reasonable Accommodation

Bright Research is committed to providing reasonable accommodations to qualified individuals with disabilities throughout the application and employment process. If you require an accommodation to participate in the application process, please contact caeers@brightresearch dot com