Senior Quality Engineer

Job purpose

The Quality Assurance Engineer develops, applies, revises, and maintains quality metrics to support areas of operations at my client.

The role assists in the planning, development, implementation, communication, and maintenance of the 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.

Duties and responsibilities

• Lead complex tasks or 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.
• Provide technical leadership to 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.
• Serve as a technical expert of 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.
• Lead in the planning, development, review, implementation, and maintenance of Quality Assurance Policies and Standard Operating Procedures.
• Provide guidance on regulatory compliance, quality control, and risk management practices.
• 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 development and execution, as needed.

Qualifications

• Bachelor’s degree in engineering or a related technical discipline (e.g. Biology, Chemistry, etc.). Proficiency in microbiology preferred.
• At least 6-8 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)