Bruno Geron Email & Phone Number

Lewisville, Tx, Us

Manage quality oversight to ensure Good Manufacturing Practice (GMP) internally and at suppliers during the manufacturing, handling, and shipping of the Company’s products.Manage production batch records for final approval and product release.Review and approve other GMP documents including, but not limited to, manufacturing validation protocols and reports, and transportation studies.Lead and provide oversight for processing change control requests, nonconforming product dispositions, and CAPA investigations related to production.Work with various departments to plan and schedule Quality Control (QA) and Quality Assurance (QA) resources.Lead and provide oversight with respect to the proper administration and adherence of all policies and procedures to sustain a state of current Good Manufacturing Practices (cGMP) compliance at the Company.Active participant in GMP audits and inspection readiness activities to ensure Company is in a constant state of inspection readiness.Interact with government agencies during GMP inspections.Actively participate in continuous improvement activities with cross-functional teams. Pursue improvements in inspection techniques and key production metrics through the use of test method validations and statistical process monitoring.Manage supplier quality through continuous monitoring and continuous improvement activities with internal cross-functional teams and supplier teams.Direct and oversee the Calibration program.Lead Global alignment activities on Operations Quality topics.

Quality Systems made SimpleQuality Systems need to be effective, not overly-complicated, expensive or time-consuming to create or implement. Too often, when a company is considering or required to be certified to ISO Standards, there is confusion on where to start. Often large consultant groups are brought in and offer a generic solution that includes procedures, work instructions, and templates that are then adjusted to meet the specifications. I take a different and more efficient and more economical approach. I decided to create a company that will work hand-in-hand with small companies that are eager to create a simple and effective quality system representative of their company’s culture. When your team is involved versus dictated to, they will own process and the results as well as understand the value of quality.• Quality systems do not need to overcomplicated or have procedures that are lengthy, obtuse and that no one bothers to read. • Quality systems do not need an army of quality specialist to do the work.• Quality systems do not need to be for the quality department to own itContact me if you’d like a simple and effective approach to creating and implementing Quality Systems in your company. Quality Systems made Simple.

Us

• Member of Executive Team; oversees all aspects of Operations providing leadership to:Production, Quality, Regulatory, Product Engineering, Supply Chain, Reverse logistics andFacilities. • Oversee the performance of all QA functions, including product release, document control and quality assurance engineering to assure that products and processes meet company and regulatory requirements• Responsible for establishing a corporate quality assurance system and team that promotes customer satisfaction and that positively impacts the financial performance E4D. • Champion continuous improvement efforts and defect reduction initiatives to establish an effective quality management system. • Deploy Six Sigma program.• Provide assistance with scope definition, schedule and budget development and risk mitigation for critical projects/program.• Interface with all departments to provide strategic direction to meet the objectives by participating in planning & execution of critical company-wide programs and to foster collaboration and team cohesiveness.• Oversee compliance with applicable regulatory and quality requirements for products needing government approval.• Develops and maintains E4D’s Verification and Validation Program (Product Application & Business Application). This will include developing strategy documents (policies and guidance) well as writing detailed processes and procedures (SOPs) Collaboration with relevant stakeholders to ensure all aspects of verification and validation are included in E4D’s Verification and Validation Program• Responsible for protocol generation, execution, and report writing as well as oversight for staff performing similar activities. Works in conjunction with team members and stakeholders to anticipate and manage changes to projects, such as but not limited to technical requirements, business requirements and schedule.

Hillsboro, Oregon, Us

• Oversee product release, document control and quality assurance engineering to assure that products and processes meet company and regulatory requirements.• Provide technical assistance and direction to other functional groups. Interface with regulatory agencies in conjunction with new device submissions and during routine audits, field complaint investigations.• Oversee/direct the investigation of excursions in manufacturing or other related operation resulting in abnormal operation rejections. Resolve nature of cause, impact, disposition and corrective action.• Review and approves products, processes, and material related non-conformance for technical accuracy, completeness, and justification supporting recommended actions to be taken.

Valencia, Ca, Us

• Oversee the performance of all QA functions, including product release, document control and quality assurance engineering to assure that products and processes meet company and regulatory requirements.• Responsible for staffing, training and development of subordinates, and the control of financial resources.• Responsible for customer service and aftermarket service.• Responsible for all quality concerns as they relate to sales and customer care processes. This includes investigating, evaluating and reporting on customer product complaints and compliance with all legal protocols.• Provide technical assistance and direction to other functional groups. Interface with regulatory agencies in conjunction with new device submissions and during routine audits, field complaint investigations.• Oversee and/or directs the investigation of excursions in manufacturing or other related operation resulting in abnormal operation rejections. Resolve nature of cause, impact, disposition and corrective action.• Ensure that quality department policies and procedures are maintained and followed both locally and to other Bioness’ sites• Review and approve all products, processes, and material related non-conformance for technical accuracy, completeness, and justification supporting recommended actions to be taken.• Direct and assists in the development and issuance of all written procedures, bill of materials, and product drawings, ensuring that the company complies with the requirements of its cGMP’s and regulatory agencies.• Establish Quality objectives and metrics both internally and with key suppliers.• Outsourced key processes including manufacturing, distribution and engineering.

Marlborough, Ma, Us

• Generate and execute Product Validations to assurance compliance to functional specifications. • Facilitate Design Assurance/Reliability growth initiatives.• Analyze preliminary plans and develops reliability and quality engineering programs to achieve company, customer and governmental agency expectations. • Perform QA work and investigations independently, perform statistical analysis regarding reliability data.• Drive product quality improvement projects and CAPA investigations to conclusion. Became subject matter expert for engineering improvement techniques.• Qualify new supplier through process and part validation and perform validations on equipment and processes..• Investigate and analyzes relevant variables potentially affecting product and processes. • Participate in other QA activity as required, such as systematic upgrades in departmental procedures and metrics, training, generating work instructions.• Provide assistance to other engineers that are working on improvement project.

• Promote from Process Improvement/Reverse Logistics Manager to Product Quality Manager• Involve in developing a quality improvement/six sigma program (Six Sigma, 8D.)• Product quality analysis and reporting (Balanced Scorecard) using data warehouse (SAP, COGNOS).• Develop an Early Warning Process for new product including call and repair forecast.• Lead corrective and preventive action (CAR) and material review board (MRB.)• Use statistics and problem solving methodology to correct or prevent problems prior to occurrence.• Verify the supplier has effective system in place and ensure it is able to meet requirement/specification.• Develop and implement Product Quality planning using DFSS to our Product Life Cycle Process.• Develop and implement internal audit checklist that ensure compliance to Quality Management System.• Select test and reliability methods for new product.• Ramp up and manage 3rd Party reverse logistic including supplier performance metrics.• Establish End of Life and End of Repair process including forecast for parts and warranty repair.• Product quality analysis and reporting (Balanced Scorecard) using data warehouse (SAP, COGNOS).• Responsible for defining quality standard and plan for manufacturing plant and reverse logistics.• Manage team of employees including creating a Return Analysis Team.• Manage new product introduction process.• Work on optimizing Supply Chain (including inventory, material handling, and logistic flow of goods.)• Train and mentor as part of deployment of six sigma training class

Espoo, Southern Finland, Fi

• Analyze Batch and Field Failure Rate of specific products using data warehouse (SAP, COGNOS).• Drive action to reduce returns rate and customer service by working with different group.• Provide Product Quality report (Balanced Scorecard) to executive staff and Customers.• Manage Process/Quality improvement project using Six Sigma methodology.• Write Visual Basic application and maintain several databases.• Work on several Six Sigma project (certified Black Belt and trained as Master Black Belt.)• Develop a new product audit process and contribute in the development/improvement of new phones.• Create software tools to help to test the phone using C++ and Lab View.• Develop and present technical training programs for customers and in-house employees.• Supervise and train technician on troubleshooting the different phones.• Write technical document and reports on the test equipment or the phone itself.

• Manage, verify, configure and install Mobile communication device.• Analyze implementation of new RF site including propagation analysis to determine feasible RF site.• Program, install and maintain multiple RF site.• Keep in the state of readiness digital recording systems and all communications equipment.