Heller Genao Email & Phone Number

United States

San Clemente, CA, US

• Spearheaded the EU MDR Remediation initiative for the Consumables Business Unit, ensuring compliance and strategic alignment.
• Directed New Product Introduction (NPI) and Sustaining projects, overseeing a diverse portfolio.
• Developed and managed a project budget exceeding $5MM, ensuring optimal allocation and financial oversight.
• Strategically identified resource requirements and led a team of staff and contractors to achieve efficient project execution.
• Utilized MS Project to create and maintain comprehensive project schedules, ensuring timely delivery.
• Provided executive-level updates on project status, budget, and timelines, tailoring communication to suit various stakeholders.

Stamford, CT, US

- Founder of Levox Consulting Services firm.- QMS establishment for ISO9001 and ISO13485- Schedule, execute and investigate Internal Audits.- Support CAPA and Non-Conformance investigations- Provide training and various elements of the QMS.

Marlborough, MA, US

• Supported the strategic transfer of Manufacturing Operations from the Connecticut site to the new Delaware site, ensuring seamless transition and operational continuity.
• Conducted in-depth gap assessments and spearheaded remediation activities to support the 'Transfer as Is' process, driving operational efficiency and sustainability.
• Implemented robust change management strategies to align teams and processes with the new operational framework, fostering a culture of adaptability and continuous improvement.
• Engaged with senior leadership and key stakeholders to communicate strategic goals, progress, and outcomes, ensuring alignment with organizational priorities.
• Identified and mitigated potential risks, safeguarding project timelines and maintaining high-quality standards.

Wayne, PA, US

• Led the Risk Management Files (RMF) project for the market release of an expanded indication of a registered product for the US market.
• Took over an ongoing project, guiding a small team to complete critical risk management activities, including User Failure Modes & Effect Analysis (FMEA), Design FMEA, Process FMEA, Risk Analysis & Control Tables.
• Successfully completed and released the RMF Package through the Document Control System, ensuring compliance and readiness for market release.
• Exceeded expectations by completing the RMF Package two months ahead of schedule, thanks to strategic project management, clear task delineation, stakeholder engagement, and effective use of consultants.
• Submitted the RMF Package for FDA audit with no findings, meeting stringent 21CFR 820, ISO 14791, and ISO 13485 requirements, demonstrating robust compliance and quality assurance.

• Influenced senior leadership by aligning quality management initiatives with the organization's vision, providing strategic insights and regular updates to drive informed decision-making and long-term planning.
• Directed a team of engineers and contractors, collaborating with Manufacturing and Engineering to support Operations, facilitate Product Transfers, and maintain the Quality Management System (QMS) at the Trumbull site.
• Developed and implemented key performance indicators (KPIs) for Corrective and Preventive Actions (CAPA), aligning initiatives with the broader strategic goals by the organization. Delivered comprehensive Root Cause.
• Achieved a 100% reduction in the backlog of reportable complaint investigations, ensuring long-term compliance with regulatory requirements for open reportable complaints within 60 days.
• Reduced Non-Conformance Report (NCR) cycle time by over 400%, from an average of 180 days to 12 days, significantly improving manufacturing productivity. Eliminated 95% of the backlog, enabling the disposition of.
• Directed eQMS data integration and PLM feasibility evaluations, collaborating with vendors for global system implementation. Identified critical deficiencies, preventing a potential $0.3MM loss and ensuring long-term.

Wayne, PA, US

• Recognized a need for an effective Quality System Integration and parallel QMS functioning due to integration of former Z-Medica into Teleflex Inc. I took the leadership for the site integration for all elements of the.
• Implemented SAP QMS (eQMS) for CAPA, Complaints, Audits, Non-conformance, Calibration, Incoming
• Inspection and Quality Control Inspection as an integration effort into Teleflex QMS.
• Created Out of Specification (OOS) and Out of Tolerance (OOT) systems for microbiology and calibration, respectively, to reduce the CAPA generation and appropriate CAPA escalation process was defined.
• Lead External Audits acquiring EU MDR Certification and MDSAP Certification. In addition, lead successful Surveillance Audits for ISO 13485 (including Microbiology and Sterilization).
• Improved the Calibration System eliminating Past Due calibrations (15% reduction to achieve 0% Past Due).

Wayne, PA, US

• Led the Quality Management System (QMS) and expanded the Quality Assurance (QA) team by implementing cross-training, redefining responsibilities, and redistributing staff. This approach developed new skills based on.
• Enhanced the Corrective and Preventive Action (CAPA) System to comply with 21CFR820 requirements by establishing a new CAPA process aligned with industry practices. Key Performance Indicators (KPIs) were created and.
• Streamlined the Paper-Based Training System, reducing documentation and retrieval time by 50%.
• Achieved an 80% reduction in quarantine backlog through the successful implementation of Material Review Board (MRB) meetings.
• Reduced Device History Record (DHR) Good Documentation Practice (GDP) errors by 50% by revamping all Device Master Record (DMR) forms, optimizing the Product Release Cycle Time from an average of 5 days to 2 days, and.
• Defined, implemented, and deployed all KPIs and Leading Indicators for the Quality Department.

Founder & CEO of FixMe Up. Responsible of company growth and presence in social media. Work directly with clients for resumes, cover letters and thank-you letters designs, professional profile boost through coaching and upgrades of the Linkedin profiles to create positive impact on recruiters.

Minneapolis, MN, US

• Identified and streamlined over 100 process indicators for the North Haven Site by partnering with Site Leadership to define and deploy a focused set of less than 15 critical KPIs. This strategic initiative enhanced.
• Revamped the CAPA Review Board (CRB) for the AST Value Stream, increasing cross-functional engagement and reducing past due tasks by 30%.
• Led the FDA Audit Back Room team, resulting in zero major findings.
• Implemented Tools of Quality (TOQ) in the Manufacturing Lines, integrating SPC and defect counts across 100% of the assigned Value Stream (Advanced Suture Therapy).
• Spearheaded the implementation of the 6S Program and Kanban system for the Office Section.
• Directed the implementation of Advanced Quality Planning (AQP), including the creation and improvement of PFMEAs, Process Maps, Flowcharts, and Quality Control Plans. This initiative was successfully implemented at the.

Moved from Dominican Republic to United States.

Irvine, CA, US

Advanced Quality Planning Leadership: Serve as the Subject Matter Expert (SME) in the creation and implementation of Advanced Quality Planning (AQP) strategies.Risk Management Oversight: Sustain and enhance risk documentation for Failure Modes and Effects Analysis (FMEAs), Quality Control Plans, and Process Mapping to ensure robust risk management.Root.

Irvine, CA, US

AQP Leadership: Serve as the Subject Matter Expert (SME) in Advanced Quality Planning (AQP) creation.Risk Management: Sustain and enhance risk documentation for FMEAs, Quality Control Plans, and Process Mapping.Root Cause Analysis: Lead and approve investigations using advanced tools such as 6Ms, 5 Why, and Cause-Effect Diagrams.Validation Protocols.

Irvine, CA, US

Non-Conformance Management: Oversee the management and disposition of non-conforming products in compliance with internal procedures and external regulatory requirements.Strategic Decision-Making: Lead product containment efforts and make critical decisions to ensure quality and compliance.Continuous Improvement: Drive continuous process improvements in.

Upgrade processes to standard practice as per ISO 9001. Create procedures to facility internal process for Mining and Services Providers companies.Improvement/redesign and implementation of internal process according to client requirements and needs. Optimize workflows. Perform Audits to Quality System Procedures. 6S Program coach.

Redesign, implementation and monitoring of internal process to fit the requirements of ISO 9001.Monitoring non-conformance quality system’s trending to implement corrective and preventive actions. Ensure compliance with procedures established. Conduct internal audits. Control, handling and calibration of measuring equipment. Assessor of Industrial Safety.

Bachelor’S Degree, Industrial Engineering

High School, Technical And Trade Administration, Major In Accounting And Administrative Management