SUMMARY:

• A Quality and Regulatory Affairs professional with over 15 years of GMP experience working for Medical Devices companies; managing in FDA/QSR, ISO9001:2008, CLIA, ISO13485:2012 quality systems as well as audit functions and Risk Management responsibilities; providing oversight role to lead the Quality Systems of the Ophthalmic, Surgical Business Instruments, Insulin Infusion Pump and accessories, Home Care Oxygen Therapeutics Medical Supply products and IVD Urinalysis Instruments. The role includes three key functional leadership aspects:
• The Quality Audits /Compliance leadership as a Management Representative, Design Control / Design Transfer, Process Validation, and Supplier Management. The individual represents the management of quality systems, establishes appropriate standards and guidelines to ensure lasting customer satisfaction.
• An effective and analytical result - oriented leader, working in Class I, II and III medical device experience, decision making, problem solving, and team building skills with strong knowledge of domestic and global regulations, CMDR, EU, ANVISA, KFDA and MDD guidelines. Extensive experience releasing complex products requires the ability to make sound decisions based on scientific and regulatory knowledge. Highly efficient project-management skills; manage multiple priorities within demanding environment. Hosted FDA authorities and successfully completed more than 30 FDA inspections and CE mark audits.

PROFESSIONAL EXPERIENCE:

Quality System Manager

Confidential, Northridge, California

• Review risk management documents, including Failure Modes & Effects Analyses (FMEA), Fault Tree Analyses (FTA), Risk Management Plan (RMP), Risk Management Report (RMR), and Risk Analysis document (RAD), Risk-Benefit analysis, and Assurance Case reports.
• Develop tools and techniques as appropriate per ISO, FDA and IEC guidelines to support risk management process.
• Lead cross-functional teams to conduct risk management activities, including but not limited to: dFMEA, pFMEA, FTA, risk assessment.
• Facilitate development of thorough, accurate and practical risk estimations, risk controls and risk/benefit analyses by cross-functional teams.
• Analyze production and field data for field returns to determine if changes to product risk profile have occurred; initiate and coordinate risk control activities as required.
• Update legacy product risk management documentation to comply with current risk management process and meet regulatory requirements.

Quality Assurance Specialist

Confidential, California

• Develop written policies and procedures required for development and manufacture of in vitro diagnostic medical devices under the directive 98/79/EC, ISO and cGMP, CLIA/QSR quality systems.
• Perform internal review and gap analysis to assess compliance, and works with Management and Staff to support and assist the quality plans.
• Perform tasks required to support design control lifecycle, such as Risk Analysis, design verification and validation, Engineering Change Orders, and new Supplier Qualifications and Monitoring systems.
• Participates as assigned as Quality representative on project team.
• Plan and perform an internal quality system audits, and execute validation protocols.
• Quality engineering support to qualify new (LIMS) software contractor.

Quality Assurance Director

Confidential, California

• Establish clear processes and metrics in line with business strategy and regulatory compliance requirements and ensure the system is in compliance with ISO, QSR, CMDR and MDD requirements.
• Directed and implement the risk management program; prepare and ensure that DFMEA, PFMEA, Health Hazard Evaluation (HHE) and Risk Analysis Reports/Risk Assessment documents are performed at production/post production, per ISO 14971:2012, EN 62304, EN 62366, and other standards.
• Maintain External References and implement, per applicable national and international regulations, standards and FDA guidance documents that affect the products and operations.
• Performs the role of management representatives for company quality and compliance systems.
• Work with R&D and Manufacturing to establish quality plans to ensure quality objectives met.
• Collaborate with CAPA Owners to manage CAPAs in the system to ensure they are well planned, effective, and completed in a timely manner
• Direct and manages strategic and tactical quality software Test Equipment and Operation systems.
• Communicate group performance against established metrics (KPI) to senior management.
• Drive timely execution of CAPA and NC deliverables through monitoring and reporting status to CAPA and NC owners and management.
• Monitor proposed regulatory changes from the FDA and other agencies including worldwide regulatory authorities and provide management with impact of changes in the Regulatory environment.
• Compile and submit device experience reports as required in accordance with US FDA Medical Device Reporting System, the EU Device Vigilance System, and any other applicable country reporting system.
• Responsible for the complaint management; ensure that MDR/VDR determination process are being performed on timely manner in accordance with domestic and international standards.

Quality System Director

Confidential, California

• Established, implement and sustain company’s quality management system, and support the regulatory affairs, clinical outcomes, complaints handling process and supplier quality program.
• Responsible for the supplier quality management program; ensure new and current supplier selection, qualification, supplier audit are completed on timely manner.
• Developed master validation plan and execute process validation protocols and reports successfully in accordance with product specification requirements.
• Developed and maintained the Calibration program for process and monitoring equipments and system.
• Worked closely with RA consultant for completion of the Technical File/Essential Requirements, per Medical Device Directives.

Global Quality Assurance Director

Confidential, California

• Ensured the R&D new and existing products development portfolio, and sustaining of the current medical devices. Assures adequate resources are present to represent design QA function and to support the company growth. Provides leadership on product project management boards and works closely in conjunction with R&D, Regulatory Affairs, Clinical, Process, and Manufacturing for design
• Submitted to the FDA several 30-or 135 Days Notices for Premarket Approval (PMA) Supplements for manufacturing method and process changes.
• Ensured that all site quality performance indicators (QPI) metrics presented to the management are in sync with site and global requirements and metrics.
• Worked directly with operating entities to ensure that management controls, product life cycle requirements including risk management, inspections, lean manufacturing, six sigma, root cause analysis tools, statistical process control analyses and internal & external audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
• Established the development and maintenance of the quality assurance programs; policies, processes, procedures, and controls ensuring that performance and quality of products conform with establish standards and agency guidelines. Reviews, analyzes and reports on quality discrepancies related to products manufactured and works closely with manufacturing to develop disposition and corrective actions for recurring discrepancies.
• Directed and coordinated all aspects of site strategic planning and quality assurance programs, such as development and administration, training, coaching employees, and facilitating through the organization.
• Responsible for the organizational structure changes/alignment with B+L corporate quality system.
• Responsible for managing the quality integration plan into the transformation Plan: NC/CAPA CQMS 2.0, Change Management, Documentum 6.5 and Compliance Wire.
• Performed Quality Planning Tool to assess site quality systems versus global quality system and where needed make appropriate changes to the local quality systems.
• Represent the site externally with domestic and international regulatory agencies to provide information and solve problems.
• Developed and implemented standards and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of B+L products.
• Monthly reporting to the senior functional management on the CAPA/NC and Complaint handling performance and other quality system activities.
• Managed site internal and external audit preparation ensuring all elements of quality systems are being managed effectively and in timely manner.
• Participated in industry and regulatory surveillance to ensure that the highest standards are maintained through on-going communication and training.
• Responsible for leading development and management of effective compliant quality systems, working closely with various cross functional members of site to ensure all requirements described meet the needs of regulations and functional excellence.
• Assists in the development and monitoring of department budgets.

Quality Assurance Specialist

Confidential,California

• Maintained the quality reporting system to communicate and resolve product quality issues throughout the organization up to the Executive Management with the overall goal of continually improving product quality.
• Established QC/QA Plans and assist other departments in quality planning activities as well as supporting and providing an internal training program for the QC inspector and supervisors.
• Oversaw QA/QC efforts and provide strong counsel regarding manufacturing of devices.
• Responsible for monitoring /trending the environmental data for clean rooms, water systems.
• Directed the supplier quality program; supplier corrective action, qualification and rating.

Quality Assurance & Regulatory Affairs Director

Confidential, California

• Coordinated all aspects of company quality and regulatory programs, such as development of new and existing products and administration, training, coaching employees, and facilitating throughout the organization.
• Directed and oversee the preparation of all required documentation for submissions of the 510(k) and Technical File to appropriate governmental regulatory agencies or notified body.
• Represented the Company externally with domestic and international regulatory agencies to provide information and solve problems.
• Developed and implement standards and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company’s products.
• Ensured that QC/QA & RA activities are planned; resources allocated; priorities established and activities executed to meet business goals, including:
• Lot release of components, raw materials and finished products.
• Quality and regulatory compliance of operations.
• Validation of process, software and products.
• Document control and change control system.
• Failure investigation and CAPA programs.
• Internal and third party audits.
• Hosting FDA and Notified Body audits.
• Participated in industry and regulatory surveillance to ensure that the highest standards are maintained through on-going communication and training.

Senior Staff Quality Assurance Engineer

Confidential, California

• Developed and implemented Design Assurance/Qualification/Validation Master Plan and Schedules for new and existing products and processes.
• Performed Essential Requirement Matrix, FMEA/FTA and Risk Analysis for new/existing products in conjunction with R&D, Manufacturing Engineering, Supplier Quality Assurance, Regulatory Affairs, Marketing and other Service Groups.
• Established and monitored the quality standard based on internal and external specifications.
• Assured conformance to stated specifications through the implementation of statistically valid sampling plans and process validations.
• Established vendor reliability ratings, device probability studies of failure, and counsel with design engineers in parts design and application.
• Maintained the approved vendor list to identify for use only those vendors capable of meeting agreed upon specifications.
• Coordinated and facilitated MRB activities as well as directly supported the incoming, in process and final inspection.
• Coordinated with CE, UL, and CSA testing of new products and maintained certification.