Quality Project Manager

KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:  

• Assists Associate Director of Quality in coordinating and executing goals and objectives throughout the company to improve product quality and operating system efficiency.   
• Direct and coordinate the activities of Quality Department employees.  
• Establish and maintain sound relationships with production, technology, supply chain, quality teams and cross functional personnel to identify system and compliance gaps with proposed resolutions.  
• Act as liaison with metrology, QC and compliance team
• Ensure adherence to project and company standards, while maintaining quality systems that meet customer, internal, and regulatory requirements (ISO, cGMP, FDA, Health & Safety).
• Manage claims non-conformities, investigations, problem solving, root cause analysis, champion creation of effective and sustainable corrective actions.  
• Manage process and equipment Validations for new product and existing business.
• Change control process owner
• Define and implement quality initiatives to meet KPI’s and objectives.   
• Identify opportunities for improvement through data trending and analysis, as well as develop and implement quality and inspection processes. Engage in risk assessment process; data integrity, control and management utilizing risk assessment tools such as FMEA.  
• Review and approve technical protocols, reports, and specifications, as appropriate.
• Participate and lead CAPA activities as required, utilizing problem solving techniques to reduce internal and external failures.  
• Employ necessary tools/resources and perspectives, treating all co-workers with respect/dignity and valuing feedback.    
• Responsible for the coordination and evaluation of the Quality department.   
• Supervises staff in line with company policies and laws, including hiring, training, task management, performance evaluation, discipline, and conflict resolution.
• Make hiring decisions for their direct reports.     
• Represent the Quality Department in support of customer, ISO and third-party audits.  
• Other duties as assigned