Quality Engineer

EVERSANA INTOUCH® is a global, full-service marketing agency network serving the life sciences industry. The Quality Engineer will design and implement performance and quality improvement projects, ensure compliance with the Quality Management System, and assist in improving business processes and services.

Responsibilities:

• Drive, facilitate and report on site performance and quality improvement projects and team activities
• Review and analyze data to provide direction for site investigations, and corrective and preventive actions (CAPA), and/or process improvement activities
• Assess the state of compliance against established procedures and collaborating with site Operations to remediate items that are out of compliance
• Provide quality engineering tools, methods and training to the staff
• Lead process analysis and control activities
• Support the business unit and coworkers with quality and compliance issues
• Assist in the coordination of Performance & Quality Improvement activities including planning, identification of objectives and reporting results
• Establish, follow and improve corporate and site procedures and associated instructions and resource documents
• Understand and communicate sources of variation and risk that can affect DLSS services and processes
• Provide written and oral reports to corporate and site leadership to keep them informed of improvement activities and results, which can be in the form of presentations, storyboards, etc
• Participate in business process design and improvement activities
• Evaluate and improve quality information systems
• Administer the site CAPA system
• Direct, manage and implement the internal assessment program, including:
• Annual risk assessments and audit scheduling
• Training internal auditors
• Ensuring documentation is completed and findings reported
• Findings are remediated in a timely manner
• Monthly, quarterly and annual reporting, and the development of key performance indicators (KPIs)
• Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. All other duties as assigned

Requirements:

• Bachelor's degree in engineering, mathematics/statistics or technical science
• 3+ years prior work experience in a quality, healthcare or life sciences role
• Industry certification required (ASQ Certified Quality Engineer (CQE), Technician (CQT), Auditor (CQA) or Process Analyst (CQPA), Six-Sigma Belt, etc.)
• Proficient in the use of MS Office programs, specifically Excel, Word and PowerPoint
• Excellent verbal, written, and consultative communication skills
• Ability to manage multiple priorities and meet organizational goals
• Ability to work with staff at all levels of the organization