Create a Process Structure. The Quality Manager will lead the implementation of a process structure that incorporates quality points that become intrinsically linked to the process itself. Where restructuring of existing processes is required, Quality Manager must work with key stakeholders to manage changes and communicate new quality responsibilities to process owners.
Create a Process Structure. The Director of Supply Chain support the implementation of a process structure that incorporates quality points that become intrinsically linked to the process itself. Where restructuring of existing processes is required, Director of Supply Chain must work with key stakeholders to manage changes and communicate new supply chain responsibilities to process owners. COMMERCIALIZATION ROADMAP: Upon start date, the Director of Supply Chain under the guidance of the CQO must understand the current status and how many elements of this plan have been completed or are not yet in place. The Director of Supply Chain will support the CQO in leading a cross functional team consisting ofR&D, Marketing, Regulatory, Clinical, Quality & Manufacturing to define each step. Employee signs off and attests to the fact that Employee meets or exceeds the requirements of Exhibits A & B and accepts these job responsibilities which may change from time to time. Duties and Responsibilities may be updated and changed by the CEO. Employee agrees to accept other duties and responsibilities that may be determined by the CEO. By: /s/ Xxxxxx Xxxxxx EXHIBIT B GOALS: • Assist and support the design (DFQ, DFM, DFA & DFT) and development of the biosensor platform and its continued advancement, including new pathogen detection capabilities. • Build and implement a best-in-class Supply Chain and Quality Management System (QMS). • Build and maintain a corporate-wide culture of quality that enables successful execution of corporate growth strategy. • Under guidance of CQO, lead the development, maintenance and implementation of the Quality Plan to ensure adequate inventory, Quality Objectives and the Quality Policy are met. • Ensure compliance with all relevant ISO and FDA GMP regulatory requirements (e.g., ISO 13485, 21 CFR 820) and provide necessary documentation and training to staff. • Develop, implement and manage risk management documentation (product hazard analysis, pFMEA) and use of risk management techniques. • Lead quality supply chain and assurance resources and interact with cross-functional departments to provide quality guidance. • Lead supply chain effort and be responsible for managing multiple complex manufacturing support activities. Establish continuous improvement projects to facilitate manufacturing and inventory support activities. • Be a leader that is willing to do anything it takes to be successful. By: /s/ Xxxxxx Xxxxxx EXHIBIT C Salary shall be $8,958 less all withhold...
Create a Process Structure. The CQO is responsible for providing a process structure that incorporates quality points that become intrinsically linked to the process itself. Where restructuring of existing processes is required, CQO must work with key stakeholders to manage changes and communicate new quality responsibilities to process owners.
Create a Process Structure. The Director of Quality will lead the implementation of a process structure that incorporates quality points that become intrinsically linked to the process itself. Where restructuring of existing processes is required, Director of Quality must work with key stakeholders to manage changes and communicate new quality responsibilities to process owners. Employee signs off and attests to the fact that Employee meets or exceeds the requirements of Exhibits A & B and accepts these job responsibilities which may change from time to time. Duties and Responsibilities may be updated and changed by the CEO. Employee agrees to accept other duties and responsibilities that may be determined by the CEO. By /s/ Xxxxx Xxxxxxx EXHIBIT B GOALS: · Assist and support the design (DFQ, DFM, DFA & DFT) and development of the biosensor platform and its continued advancement, including new pathogen detection capabilities. · Build and implement a best-in-class Quality Management System (QMS). · Build and maintain a corporate-wide culture of quality that enables successful execution of corporate growth strategy. · Under guidance of CQO, lead the development, maintenance and implementation of the Quality Plan to ensure Quality Objectives and the Quality Policy are met. · Ensure compliance with all relevant ISO and FDA GMP regulatory requirements (e.g., ISO 13485, 21 CFR 820) and provide necessary documentation and training to staff. · Develop, implement and manage risk management documentation (product hazard analysis, pFMEA) and use of risk management techniques. · Lead quality assurance resources and interact with cross-functional departments to provide quality guidance. · Lead effort and be responsible for managing multiple complex manufacturing support activities. Establish continuous improvement projects to facilitate manufacturing support activities. By /s/ Xxxxx Xxxxxxx EXHIBIT C Salary shall be $9,533 less all withholding amounts per pay period (twice per month at about the 15th and the first day of the next month but these days may vary) for twelve months. Health Benefits include a maximum reimbursement for a single or family HSA-qualified plan. Health Benefits also include a maximum monthly reimbursement of $1,000 a month for Affordable Care Act (ACA) health insurance coverage. 401K Plan- Employee will be eligible to participate as soon as the Company adopts a plan for its employees. Employee is eligible for a SEP retirement plan of up to $583 a month. Vacation & Holidays-...
