Sr. Quality System Specialist

• Feb 2019 - Present

QMS compliance: * Initiate, facilitate, and manage projects to expand, enhance, and improve the QMS. * Create, review, and maintain QMS procedures. External Audit/Inspection support: * Led back and front rooms during FDA inspections and notified body audits for MDSAP/ISO 13485 re-certifications. Lead External Standards Review Board: * Lead efforts to ensure compliance of emerging standards by monitoring the release of new standards that may affect product or the QMS and maintaining master list of applicable standards. * Conduct gap assessments of new regulations, standards, and guidance documents. Drive resolution of the gaps to ensure ongoing QMS and product compliance. * Coordinate review of gap assessments with cross-fuctional External Standards Review Board to ensure that changes are reviewed in a timely manner, gaps are identified and appropriately addressed with action plan, and implemented into the QMS. Coordinate CAPA board: * Led and hosted monthly CAPA team meeting to review CAPA requests, investigations, and open CAPA status. * Calculated and reported monthly CAPA KQM. * Mentor and coach CAPA owners to execute effective investigation, root cause analysis, and verification plans. Key Quality Measures: * Coordinated monthly meeting with executive committee to review and present current KQM results and QA/RA updates. * Propose Quality Systems KQM to effectively monitor the effectiveness of the QMS. Coordinated global internal audit program: * Led internal audit team by creating/maintaining audit schedule, supporting auditors-in-training, and leading monthly meeting to review KQM, audit results, and QMS updates. * Served as Lead Internal Auditor for internal audits at US and EU sites. Lead Document Control team: * Manage expectations by active communication with stakeholder and team. * Supervise, mentor, advise, and hire Quality System Specialists in document control. Show less

Sr. Quality Engineer

• Feb 2018 - Feb 2019

Ensured the quality requirements were established implemented and maintained in accordance with the current ISO 13485 Standard, 21 CFR Part 820, and 21 CFR Part 210/211 regulations.Ensured the Quality Management System activities were developed and deployed in an efficient and effective manner that supported the company's Quality objectives.Analyzed production quality issues and managed the identification, documentation, segregation, investigation, and disposition of any potentially non-conforming product.Supported production and process change control through review and approval of documentation, ensuring adequacy of verification or validation to support the change, good documentation practices and compliance to procedures.Oversaw the supplier qualification process, including performing supplier audits and resolving supplier quality issues.Supported the internal audit program as a lead auditor.Supported regulatory and customer audits.Led Corrective and Preventive actions (CAPA), customer complaints, and deviations to resolve production and customer issues.Participated in software and system validation activities.Performed statistical analysis of data and product specifications to evaluate present standards and achieve quality targets. Participated as QA lead in development projects to ensure products and processes are designed, developed and transferred to meet appropriate requirements. Maintained monthly key quality measures related to the internal audit program, supplier management, and investigation systems.Accountable for identifying and implementing GMP (Good Manufacturing practices) that apply to a specific product area.Identified and implemented continuous improvement activities as it relates to product quality. Show less

Quality Engineer

• Sep 2016 - Feb 2018

Research Associate

• 2010 - 2015

Managed project that increased precision of critical analysis by 40%. Enabled eight colleagues to successfully deliver results conforming to strict quality requirements using statistical analysis. Communicated results to stakeholders. Prospective buyers needed data on short notice, but limited understanding of process required site-wide project with focused leadership to deliver on time and solve problem. Reduced frequency of analyst error to less than 1% by systematizing four-day-long assay using innovative strategies, which resulted in more efficient use of resources and decreased time to deliver results. Previously, frequency of retesting was high as a result of the sensitive and complex nature of the assay, and it was assumed this analyst error was an inherent issue. Created innovative system of measuring sugar production using cutting-edge infrared modeling technology. Delivery time decreased from one week to one day, and work load decreased from 1-½ to ½ full-time employees. Received three formal commendations from leadership for successfully building teams on site during stressful times, when the sharing of communication was most important. Show less

Laboratory Analyst

• 2007 - 2010

Helped minimize the public impact of 2009 swine flu pandemic by running quality control assays conforming to FDA standards to manufacture and deliver component needed for H1N1 medication. Helped minimize the public impact of 2009 swine flu pandemic by running quality control assays conforming to FDA standards to manufacture and deliver component needed for H1N1 medication.

UROP Researcher

• 2006 - 2006

Awarded entry into Undergraduate Research Opportunities Program. Worked in conjunction with faculty researching new methods of peptide synthesis. Utilized HPLC and NMR instrumental analyses. Awarded entry into Undergraduate Research Opportunities Program. Worked in conjunction with faculty researching new methods of peptide synthesis. Utilized HPLC and NMR instrumental analyses.

Job Site Manager

• 2005 - 2005

Managed team of 3-6 painters on large projects to paint house exteriors. Strategized and executed plans for painting of houses, garages, and patios under tight deadlines. Communicated between clients to understand their needs and painters to ensure high-quality work was completed within the promised time frame. Managed team of 3-6 painters on large projects to paint house exteriors. Strategized and executed plans for painting of houses, garages, and patios under tight deadlines. Communicated between clients to understand their needs and painters to ensure high-quality work was completed within the promised time frame.