MGC Diagnostics · 1 day ago
QA Document Control Specialist
Twin Cities Area
Full-time
Onsite
Mid Level
$70K/yr - $85K/yr
3+ years expMGC Diagnostics is focused on managing and improving document control processes to ensure compliance with regulatory and quality standards. The QA Document Control Specialist oversees the lifecycle of controlled documents, ensuring accuracy and accessibility while supporting internal and external audits.
Health CareHealth DiagnosticsMedicalMedical Device
Hiring Manager
Jordan Ochoa
Responsibilities
Maintain and control all MGC’s documents including Standard Operating Procedures, Procedural Work Instructions, forms, specifications, and records using document management system
Ensure proper document routing, review, approval, issuance according to internal procedures
Perform periodic review of controlled documents to ensure continuous accuracy and relevance
Assist with establishing Adobe electronic signatures for new employees or when digital ID’s have expired
Maintain QMS logs associated with control of documents
Ensure adherence to record retention and archival practices
Support internal and external audits
Act as a liaison between departments to ensure clarity and consistency in documentation practices
Support Quality Systems Manager with monitoring CAPA System
Participate in quality initiatives and other assignments
Identify process inefficiencies within document workflows and propose enhancements
Transition from paper-based to electronic documentation and workflows
Assist the QARA team with redlines and routing of Engineering Change Orders
Qualification
Required
Associate or bachelor's degree in, Business, Life Sciences, or related field (preferred)
Minimum of 3 years of experience with degree, or 5 years of experience in document control, quality assurance, or quality systems role within the medical device or other regulated industry
Strong understanding of document control principles and quality management systems (QMS)
Familiarity with ISO, FDA, GMP/GLP, or similar regulatory standards
Proficiency with Microsoft Office, Adobe PDF and fillable forms, Vizio or other document tools
Excellent attention to detail, organization, and time-management skills
Strong communication skills and ability to work cross-functionally
Preferred
Familiar with regulatory standards such as EUMDR and Medical Device Single Audit Program (MDSAP)
Knowledge with EQMS (Electronic Quality Management System)
Company
MGC Diagnostics
MGC Diagnostics develops non-invasive diagnostic systems for detecting and managing cardiorespiratory disease.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2022-11-29Acquired
2003-01-17IPO
Leadership Team
Lew Schildkraut
Chief Financial Officer
Recent News
Research and Markets
2025-04-08
Company data provided by crunchbase