What are the responsibilities and job description for the Quality Systems Manager position at VisionFirst - Indiana Lions Eye Bank?
About Us:
VisionFirst is a leading nonprofit organization dedicated to restoring sight through the recovery, processing, and distribution of ocular tissue for transplantation and research. We are committed to the highest standards of quality and patient safety, ensuring life-changing opportunities for those in need.
We are seeking a Quality Systems Manager to oversee our Quality Management System (QMS) and ensure compliance with FDA, EBAA, and other regulatory standards. If you have a passion for quality assurance in healthcare and want to make a meaningful impact, we encourage you to apply!
Key Responsibilities:
Regulatory Compliance & Accreditation
- Ensure adherence to FDA (21 CFR Part 1271), EBAA, and Good Tissue Practices (GTP) requirements.
- Serve as the primary liaison for regulatory audits and accreditation inspections.
- Maintain and update Standard Operating Procedures (SOPs) to align with changing regulations.
Quality System Oversight
- Develop, implement, and monitor the Quality Management System (QMS).
- Conduct internal audits, risk assessments, and process improvements.
- Investigate non-conformances, implement Corrective and Preventive Actions (CAPA), and track follow-ups.
Training & Process Improvement
- Train staff on quality policies, procedures, and compliance requirements.
- Collaborate with clinical teams to enhance tissue recovery, processing, and distribution quality.
- Promote a culture of continuous quality improvement.
Documentation & Reporting
- Maintain accurate quality records, logs, and regulatory reports.
- Ensure compliance with document control and version tracking.
- Prepare reports for regulatory agencies, board members, and leadership.
Qualifications:
Education: Bachelor’s degree in Life Sciences, Healthcare Administration, Quality Management, or related field.
Experience: 3–5 years in quality assurance, regulatory compliance, or tissue/eye banking.
Skills:
- Strong knowledge of FDA, EBAA, AATB standards.
- Experience with audits, inspections, and CAPA systems.
- Excellent communication, problem-solving, and organizational skills.
- Proficiency in Microsoft Office and quality management software.
Why Join Us?
Impactful Work – Help restore sight and improve lives!
Growth Opportunities – Ongoing training and career development.
Great Benefits – Competitive salary, health insurance, retirement plans, and more!
Supportive Team – Work with professionals passionate about making a difference.
Job Type: Full-time
Pay: From $85,000.00 per year
Schedule:
- 8 hour shift
- Monday to Friday
Ability to Commute:
- Carmel, IN 46280 (Required)
Ability to Relocate:
- Carmel, IN 46280: Relocate before starting work (Required)
Work Location: In person
Salary : $85,000