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Lions World Vision Institute · 5 hours ago

Quality Assurance Manager

Tampa, FL

Full-time

Onsite

Senior Level

$62K/yr - $73K/yr

5+ years exp

Lions World Vision Institute is seeking a Quality Assurance Manager responsible for executing and maintaining their Quality Management System. This role involves ensuring compliance with FDA requirements and accreditation standards while leading quality processes, investigations, and audits.

Health CareMedicalNon Profit

Responsibilities

Oversee day-to-day execution of the Quality Management System (QMS) and ensure consistent implementation across operations

Manage and maintain controlled documents, records, and change control processes to ensure ongoing regulatory compliance

Lead investigations of deviations, nonconformances, adverse events, and complaints; perform root cause analysis and manage CAPA activities to closure

Coordinate and support regulatory inspections, audits, and assessments, including preparation, hosting support, response development, and follow-up actions

Plan and conduct internal audits and vendor/partner audits; track and verify timely completion of corrective actions

Supervise environmental monitoring, validations, and qualifications for facilities, equipment, and processes in collaboration with Operations

Ensure training and competency programs are executed, documented, and maintained in compliance with regulatory and accreditation requirements

Monitor quality metrics and trends; prepare reports and escalate risks, compliance issues, and improvement opportunities to the QA Director

Provide hands-on guidance to operational teams on SOP adherence, regulatory expectations, and quality best practices

Support continuous improvement initiatives and cross-functional projects as assigned by the QA Director

Maintain current knowledge of FDA, relevant state, and OSHA regulations as well as AATB and EBAA standards; keep informed on industry changes, trends, and best practices

Qualification

Quality Management SystemsFDA RegulationsAuditingCAPA ManagementInvestigative SkillsTrainingLeadership ExperienceMentoringMicrosoft OfficeAnalytical SkillsInterpersonal SkillsProblem-Solving SkillsTime Management

Required

Bachelor's degree from an accredited four-year college or university preferred

Minimum of 5 years' experience in quality or regulatory within tissue banking preferred

Minimum of 3 years' experience in a leadership role preferred

Proven ability to train and mentor staff

Experience with the interpretation and practical application of FDA regulations, procedures, and guidelines that govern quality systems is preferred

Industry certifications (CEBT and CTBS) required, or must obtain both with 1 year of employment

Preferred

ASQ CQA preferred

Must have strong verbal, written, and analytical skills

Effective interpersonal skills: ability to develop and maintain positive relationships with professional contacts, resources and/or networks and deal with people with sensitivity, tact, discretion and professionalism

Experience with Microsoft Office Programs including: Word, SharePoint, Teams, Excel, Visio, etc

Strong investigative and problem-solving skills

Strong knowledge of quality management systems and audit methodologies

Exhibit a high degree of professionalism and etiquette

Must be able to effectively work independently and within a team

Able to manage time and prioritize constraints as well as the ability to manage multiple priorities/tasks simultaneously

Outcome driven; can thrive in a fast-paced environment while effectively managing pressure in a professional manner