Contour Light®
Part-Time Quality Assurance – Documentation Control
Contour Light®, Reno, Nevada, United States, 89550
Part-Time Quality Assurance – Documentation Control
We are a medical device manufacturing company specializing in Class II FDA-regulated devices. Our mission is to deliver safe, effective, and compliant products to improve patient outcomes. We are seeking a part-time Quality Assurance professional to support our documentation control processes, ensuring compliance with FDA regulations and ISO standards.
Key Responsibilities
Manage document control processes including creation, review, approval, issuance, revision, and archival of controlled documents (SOPs, work instructions, quality records, forms, etc.).
Ensure compliance with FDA QSR (21 CFR Part 11 & 820) and ISO 13485 documentation requirements.
Support internal and external audits by maintaining organized and accessible records.
Coordinate document change requests, ensuring proper approvals and implementation.
Train and guide staff on document control procedures and proper documentation practices.
Monitor and maintain records of device history files (DHFs), device master records (DMRs), and design history files.
Track document status and maintain document control databases or electronic quality management systems (eQMS).
Support CAPA, nonconformance, and other quality system processes as needed.
Qualifications
Associate’s or Bachelor’s degree in a scientific, technical, or quality-related field preferred.
Minimum 2 years of experience in Quality Assurance or Document Control in an FDA-regulated environment (medical device industry strongly preferred).
Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and document control best practices.
Experience with electronic document management systems (EDMS/eQMS) is a plus.
Excellent attention to detail, organizational skills, and ability to manage multiple priorities.
Strong communication skills, both written and verbal.
Schedule & Work Environment
Part-time role: approximately 15–20 hours/week – adjust as needed.
Flexible schedule with potential for hybrid/remote support (depending on company systems and policies).
Reports to: Quality Assurance Manager.
Why Join Us
Opportunity to contribute to patient safety and healthcare innovation.
Collaborative, compliance-driven, and mission-focused team.
Flexible part-time work with growth potential.
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Key Responsibilities
Manage document control processes including creation, review, approval, issuance, revision, and archival of controlled documents (SOPs, work instructions, quality records, forms, etc.).
Ensure compliance with FDA QSR (21 CFR Part 11 & 820) and ISO 13485 documentation requirements.
Support internal and external audits by maintaining organized and accessible records.
Coordinate document change requests, ensuring proper approvals and implementation.
Train and guide staff on document control procedures and proper documentation practices.
Monitor and maintain records of device history files (DHFs), device master records (DMRs), and design history files.
Track document status and maintain document control databases or electronic quality management systems (eQMS).
Support CAPA, nonconformance, and other quality system processes as needed.
Qualifications
Associate’s or Bachelor’s degree in a scientific, technical, or quality-related field preferred.
Minimum 2 years of experience in Quality Assurance or Document Control in an FDA-regulated environment (medical device industry strongly preferred).
Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and document control best practices.
Experience with electronic document management systems (EDMS/eQMS) is a plus.
Excellent attention to detail, organizational skills, and ability to manage multiple priorities.
Strong communication skills, both written and verbal.
Schedule & Work Environment
Part-time role: approximately 15–20 hours/week – adjust as needed.
Flexible schedule with potential for hybrid/remote support (depending on company systems and policies).
Reports to: Quality Assurance Manager.
Why Join Us
Opportunity to contribute to patient safety and healthcare innovation.
Collaborative, compliance-driven, and mission-focused team.
Flexible part-time work with growth potential.
#J-18808-Ljbffr