The Sr. Quality Assurance Engineer develops, applies, revises, and maintains quality metrics to support areas of operations at Vivex Biologics, Inc. Serves as a mentor to the Quality Engineer Specialists and Quality Engineers I/II. The role assists in the planning, development, implementation, communication, and maintenance of Vivex's quality management systems, polices, documentation, data, and customer requirements. The Sr. 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

Duties and responsibilities

• Independently lead specific tasks or larger projects and ensure their successful completion.
• Lead structured root cause investigations to drive effective corrective actions
• Initiate, lead, and/or support CAPA system items: non-conformances, deviations, corrective and preventive actions, supplier corrective actions, and complaints.
• Identify, initiate, lead, and/or support process improvement activities and support.
• Collaborate with the Subject Matter Experts (SMEs) to perform investigations within the various CAPA systems and cross-functional teams to ensure they are correctly, clearly, and completely documented in compliance with procedural and technical writing requirements.
• 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.
• Mentor and guide other engineers, fostering their technical growth and professional development.
• Support validation activities, including protocol review and approvals, as needed.

Qualifications

• Bachelor's degree in engineering or a related technical discipline (e.g., Biology, Chemistry, etc.). Proficiency in microbiology preferred.
• At least 5-6 years of experience in related Engineering or Quality role.
• Strong knowledge of FDA, AATB, 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.

Working conditions

Office environment, laboratory environment, occasional clean room access, subjected to human tissue and associated hazards and biohazards.

Physical requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.

Direct reports

No direct reports (Individual contributor role)

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.