.Manage operations and continuous improvements of the key quality systems including CAPAs, Deviations, Supplier Control, Audit Program and Technical Support, to ensure compliance with federal and global regulatory requirements. Oversee performance of the Quality teams and provides expertise to ensure the processes are well established and Quality Objectives are met. Analyzes trending data to proactively identify and alert senior management of quality issues. Provides recommendations for process improvements and ensures the improvements are implemented and achieved.**Essential Duties and Responsibilities**CAPAs- Overall management of the company's CAPA program.- Conduct site-wide training on the CAPA program and its best practices, including Root-cause analysis and Risk Assessment.- Work with CAPA owners and provide guidance and expertise on all stages of the CAPA lifecycle.- Trending and analysis of CAPA data.- Ensure regulatory compliance of the CAPA files and practices.- Act as SME for CAPAs during Regulatory and Customers audits.Customer Complaints and Technical Support- Ensure compliance of the Customer Complaints and Technical Support processes with internal procedures and Regulatory requirements- Review and evaluate investigation reports, including Root Cause Analysis and Risk Assessment, to ensure appropriate actions were taken- Lead cross-departmental efforts to resolve customer concerns and questions.- Provides leadership to the team to ensure product knowledge and employment of the best industry practices.- Conduct periodic analysis to identify trends and generate reports.Supplier Program- Develops and manages processes for initial qualification and continual monitoring of supplier performance- Ensures implementation of sufficient level of controls, based on risk and supplier performance.- Generates Quality agreements and supplier surveys.- Maintains approved supplier's files and records; - Ensures SCARs are issued and improvements implemented.Audits- Facilitates and improves company's Audit program and conducts Internal and Supplier Quality Audits.- Drives QMS improvements based on audit data.- Participates in external audits as SME for CAPAs Customer Complaints, Supplier Program, and Internal AuditOther- Support Management Review meetings and generate trending reports- Validation schedule and ensure activities are completed per schedule- Conduct QSR and other Quality System trainings.- Conducts product incoming inspection- Support Management Review meetings- Other duties may be assigned**Education and/or Experience**BS/BA degree in a science-related or technical field.Must have a minimum of 5 years Quality Systems experience, with minimum 3 years in management or supervisory role, preferably with IVD or Medical Device companies.**Required Knowledge, **Skills** and Abilities**- Working knowledge of QSRs & ISO 13485:2016; - Previous experience with participating in regulatory agency inspections
