Blood Bank Computer Systems, Inc. (BBCS) · 1 week ago
QA/RA Specialist
United States
Full-time
Remote
Entry, Mid Level
$65K/yr - $80K/yr
2+ years expBlood Bank Computer Systems, Inc. (BBCS) is seeking a Quality Assurance / Regulatory Affairs Specialist to ensure their healthcare software meets high standards of quality and regulatory excellence. The role involves maintaining quality systems, supporting regulatory compliance, and collaborating across teams to embed quality into daily workflows.
Information TechnologyMedicalSoftwareTechnical SupportTraining
No H1B
Responsibilities
Coordinate review, approval, and maintenance of SOPs and controlled documents
Ensure documentation standards, formats, and version control are consistently followed
Create and revise procedures to support scalable, compliant operations
Provide technical writing, editing, and document guidance across departments
Support change management for documentation updates
Assist with FDA audit preparation, documentation, and follow-up
Support regulatory submissions, inspections, and client communications
Maintain working knowledge of FDA regulations and applicable CFRs
Participate in urgent device client communications (UDCC) as needed
Support CAPA activities, investigations, and root cause analysis
Assist with internal quality audits and maintain audit records
Partner with teams to strengthen processes and close gaps
Help embed quality into daily workflows across the organization
Qualification
Required
2+ years of experience in QA, RA, or document control in a regulated environment
Strong technical writing and document management skills
Experience supporting CAPAs, audits, and regulatory inspections
Working knowledge of FDA regulations and CFRs (medical device/software preferred)
Excellent written and verbal communication skills
Strong organizational and prioritization abilities
Preferred
Experience with Jira and Confluence (a plus)
Experience in medical device, healthcare software, or blood/biologics environments (a plus)
Benefits
Health benefits
401k matching
Paid time off
Profit-sharing
Opportunities for professional growth
Company
Blood Bank Computer Systems, Inc. (BBCS)
BBCS has long been at the forefront of blood banking software innovation.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Beth McGee
President/CEO
Brian Forbis
President & Chief Executive Officer
Recent News
2025-09-02
Broadcastnow
2025-08-01
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