Quality & Data Analytics Manager with expertise in new product initiatives, operations, data analytics, and quality management.

Managed, led, and expanded Quality data analytics team, established harmonized, accurate quality operational reports for senior leadership across global organization, increasing analytical, financial, and operational insight.- Worked cross-functionally to collaborate and partner with peers in factories, distribution centers, customer service, finance, sales, marketing, IT, and the global regions to deliver solutions addressing enterprise-wide business needs. - Supported external and internal audits for regulatory compliance across multiple governing bodies in a global environment, FDA QSIT, 21 CFR 820, ISO 13485, MDR.- Facilitated Quality Management Review process for senior, C-suite executive leadership.

- Designed and developed standard KPIs, reporting of executive-level dashboards, metrics, and other informational delivery technologies across multiple systems- Supported external and internal audits for compliance with 21 CFR 820 and ISO 13485- Lead the development of standard reporting for the Data Analytics team- Improved utilization, reduced complexity, ensured accuracy, drove adoption of harmonization - Provided oversight to the global information delivery decisions, developed and implemented company-wide, standard business processes, oversee change for key technologies such as: Oracle, Agile, Pilgrim, Oracle Service Cloud, and other data analytical technologies- Communicated and tracked project status to executives, established and utilized project management best practices, methods, and tools.

Provided healthcare analytics for quality and safety, data coordination and management to successfully meet Hospital Engagement Network contract deliverables- Assured data integrity, quality, and accuracy- Performed ICD-10 coding transition from ICD-9 coding - Calculated return on investment (ROI) based on expenditures and cost metrics of adverse health events averted for value-based purchasing criteria- Managed data process for National Healthcare Safety Network (NHSN)- Provided technical assistance, resource information, and education on healthcare analytics for hospitals statewide- Conducted research, gap analysis, and statistical analysis providing data-driven outcomes to improve patient safety- Served on Quality and Patient Safety Committees, collaborated with key opinion leaders and resolved issues in healthcare analytics- Collaborated with CMS, CMS subcontractors, and other Hospital Engagement Networks positioning MHA as a national leader in the healthcare community.

Led cross-functional Process Improvement Project Team, directing the statistical and performance analysis of a 16 to 24-item product group, leveraging Cpk, Ppk, ANOVA, hypothesis sample and multi-QC-trending modalities, and proving product reliability, accuracy, functionality, precision performance, and marketability.- Designed/implemented Statistical Quality Control Plan, secured plan approval, and assured compliance with GLP, GMP, ISO, and CLIA regulatory requirements.- Performed root-cause and risk analysis, leveraged non-conformance (NCR) methodologies, implemented CAPA corrective action/preventative action plans, addressed/resolved non-conformance issues, and reduced product obsolescence, scrap, and backorders.- Served on Project Team that recommended evaluation, selection, acquisition, and implementation of (LIMS) Laboratory Information Management System, and positioned company for optimizing workload utilization, operational, and manufacturing processes.- Collaborated with Marketing and Customer Support Departments, targeted and resolved issues for worldwide healthcare and laboratory facility key opinion leaders and end users, optimized customer satisfaction and retention, and validated company credibility and market perception.

Conducted new product research, proved product feasibility, and deployed a multi-phased stage-gate process that facilitated numerous new product introductions.- Leveraged robust automated access platform, conducted comprehensive laboratory tests on multiple products, assured FDA regulatory compliance, and drove distribution to worldwide healthcare facilities.