Vivex Biologics · 19 hours ago
Quality Assurance Engineer II
Miami,FL,US
Full-time
Onsite
Mid Level
3+ years expVivex Biologics, Inc. is focused on developing and maintaining quality metrics to support operations. The Quality Assurance Engineer is responsible for ensuring compliance and the successful completion of projects while maintaining quality management systems.
BiotechnologyHealth CareTherapeutics
Responsibilities
Lead specific tasks or larger projects and ensure their successful completion, independently
Initiate, lead, and/or support CAPA system items: non-conformances, deviations, corrective and preventive actions, supplier corrective actions, and complaints
Collaborate with CAPA system item owners and cross-functional teams to ensure they are correctly, clearly, and completely documented in compliance with procedural and technical writing requirements
Conduct data analysis and make recommendations to ensure tissue safety/quality and compliance with standards, including the disposition of nonconforming products
Collaborate with cross-functional teams to provide Quality-related guidance, solve complex technical problems, and contribute to project milestones
Conduct trending analysis of relevant Quality metrics to recommend initiatives for improvement and/or corrective actions, as applicable
Support investigations and root cause analyses for quality-related issues, implementing effective corrective actions
Support change control activities by providing review and feedback ensuring compliance with applicable procedures and regulations
Identify potential risks associated with manufacturing processes and implement appropriate mitigation measures to minimize those risks effectively
Reports out on key Quality metrics during relevant meetings, as needed
Assist in the planning, development, review, implementation, and maintenance of Quality Assurance Policies and Standard Operating Procedures
Ensure personal and company compliance with all federal, state, company and regulatory bodies’ regulations, policies, and procedures
Support validation activities, including protocol development and execution, as needed
Qualification
Required
Bachelor's degree in engineering or a related technical discipline (e.g., Biology, Chemistry, etc.)
At least 3-4 years of experience in related Engineering or Quality role
Experience with Non-Conformance, Deviation, Complaint, and Corrective and Preventive Actions (CAPAs)
Strong knowledge of relevant software applications (Microsoft Project, Word, Excel, and PowerPoint)
Effective oral, written, communication, and presentation skills
Strong analytical and problem-solving skills
Ability to be assertive and influence others and lead significant change
Preferred
Proficiency in microbiology
Strong knowledge of FDA, AATB, ISO 13484 and cGTP guidelines
Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry
Project management skills
Company
Vivex Biologics
VIVEX Biologics' mission is to provide regenerative product solutions that help patients suffering from musculoskeletal injuries and wounds.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Chris Agle
President & COO Legacy Donor Services Foundation
Tim Ganey
Chief Science Officer
Recent News
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