Senior Manager, Global CAPA Process
Job Description The Senior Manager, Global CAPA Management is responsible for implementation of business strategies to effectively manage all CAPAs and Root Cause Investigation (RCI) processes & tools on a global basis. The Sr. Manager will manage the Olympus CAPA Process & RCI in all Olympus Global Locations and have Management Responsibility for governing the CAPA process utilized globally and act as the topmost CAPA review board as directed by the Executive Director Global CAPA Process. In addition, the Sr. Manager of Global CAPA management will manage by influence a small organization at the global level to manage Global CAPAs. This role will extensively include planning and direction with regional, local operational support & oversight as needed. Job Duties Ensure the proper execution and management of the Global CAPA process and organization Oversees execution of the Global RCI process Ensure the most appropriate tools and training is available for effective RCI. Lead the development of the Future State of the Global CAPA process and organization Support the Executive Director Global CAPA Process to manage the Global CAPA functions Budget and Headcount Manages the relationship with IT as it relates to the collection and processing of CAPA Act as global SME as it relates to all things CAPA Support the Executive Director Global CAPA Process to lead the organization that will represent the Olympus in Regulatory (global) Body inspections as they relate to CAPA management Provide CAPA KPI, trending reports and other management reports to those internal organizations that require it to meet those organizations Quality Management System requirements for Management Reviews or other ad hoc requests Job Requirements REQUIRED
Qualifications:
Bachelor's Degree in Business, Engineering, Life Sciences, or related technical degree. Minimum of 5 years leading a global or regional organization in medical devices at the Senior Manager Level or higher. Ability to travel up to 33% of time domestically and internationally. PREFERRED
Qualifications:
Strong interpersonal skills Ability to manage complexity, analytical, people management on a global basis, Office 365. Works well with different cultures Works well dealing with regulatory agencies. Strong leadership presence. We realize work isn't just a job to you. It's a big part of your life, but not the only part. That's why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks -- so you can be ready for where life can take you. Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world. Olympus' Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus' Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information
Salary Range:
$80K -- $100K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Qualifications:
Bachelor's Degree in Business, Engineering, Life Sciences, or related technical degree. Minimum of 5 years leading a global or regional organization in medical devices at the Senior Manager Level or higher. Ability to travel up to 33% of time domestically and internationally. PREFERRED
Qualifications:
Strong interpersonal skills Ability to manage complexity, analytical, people management on a global basis, Office 365. Works well with different cultures Works well dealing with regulatory agencies. Strong leadership presence. We realize work isn't just a job to you. It's a big part of your life, but not the only part. That's why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks -- so you can be ready for where life can take you. Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world. Olympus' Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus' Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information
Salary Range:
$80K -- $100K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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