Quality Assurance Engineer II

VIVEX BIOLOGICS INC • Miami, FL

3d

About The Position

The Quality Assurance Engineer develops, applies, revises, and maintains quality metrics to support areas of operations at Vivex Biologics, Inc. The role assists in the planning, development, implementation, communication, and maintenance of Vivex’s quality management systems, polices, documentation, data, and customer requirements. The Quality Assurance Engineer is expected to work with all departments to ensure compliance, that the final products are safe, reliable, and effective, and the successful and timely completion of projects. The Quality Assurance Engineer is mainly responsible for the maintenance of CAPA system items. They play a key role in preventing issues or fixing them if they arise by defining, monitoring, and approving the processes needed to achieve production standards.

Requirements

• Bachelor’s degree in engineering or a related technical discipline (e.g., Biology, Chemistry, etc.). Proficiency in microbiology preferred.
• At least 3-4 years of experience in related Engineering or Quality role.
• Strong knowledge of FDA, AATB, ISO 13484 and cGTP guidelines preferred.
• Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry.
• 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.
• Project management skills preferred.
• Ability to be assertive and influence others and lead significant change.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level