Jane Rodd Email & Phone Number

Milwaukee, Wi, Us

Birmingham, Alabama, United States

Provide oversight for the development and maintenance of quality systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.•Provide guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.•Lead audits and inspection preparation, resolution of audit and inspection findings.•Prepare reports and necessary documentation (ex Corrective and Preventative Actions) and provide to applicable stakeholders. •Ensure the quality assurance programs and policies are maintained and modified regularly.•Manage•Prepare and manage budget for department.•Develop objectives, operating policies, products, processes and standards in support of the business strategy.•Communicate with internal and external customers concerning ongoing operations, programs or processes.•Work directly with operating entities to provide process analyses oversight. •Oversee Quality Systems area of responsibility, communicate business and operational development. •Initiate programs or projects based on identified business and tactical needs. •Develop objectives, operating policies, products, processes and standards in support of the business strategy. •Communicate with internal and external customers and vendors concerning ongoing operations, programs or processes.

Memphis, Tennessee, United States

Provided quality system support to start up companies and small businesses within the Medical Device arena.Acted as the Quality Management Representative.Responsible for FDA registrations, Quality System training, customer complaints, reporting to regulatory authorities, processing document and engineering changes, CAPA, creation of Quality Plans, labeling compliance, supplier audits, ISO 13485 compliance, FDA 21 CFR Part 820, 801, 803 & 806 compliance.Represented clients during internal and external audits. (e.g. FDA, Notified bodies)

Milwaukee, Wisconsin, United States

•Provide oversight for the development and maintenance of quality systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.•Provide guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.•Lead audits and inspection preparation, resolution of audit and inspection findings.•Prepare reports and necessary documentation (ex Corrective and Preventative Actions) and provide to applicable stakeholders. •Ensure the quality assurance programs and policies are maintained and modified regularly.•Manage employees who are focused on tactical, operational and some strategic activities.•Prepare and manage budget for department.•Develop objectives, operating policies, products, processes and standards in support of the business strategy.•Communicate with internal and external customers concerning ongoing operations, programs or processes.•Work directly with operating entities to provide process analyses oversight. •Oversee Quality Systems area of responsibility, communicate business and operational development, plan, prioritize and direct the responsibilities of direct reports. Mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development. •Initiate programs or projects based on identified business and tactical needs. •Develop objectives, operating policies, products, processes and standards in support of the business strategy. •Communicate with internal and external customers and vendors concerning ongoing operations, programs or processes.

Mequon, Wisconsin, United States

•Provide oversight for the development and maintenance of quality and regulatory programs, processes and procedures that ensure compliance with policies. •Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.Lead audits and inspection preparation, resolution of audit and inspection findings.•Prepare reports and necessary documentation (ex Corrective and Preventative Actions) and provide to applicable stakeholders. •Ensure the quality assurance programs and policies are maintained and modified regularly.•Manage employees who are focused on tactical, operational and some strategic activities.•Prepare and manage budget for department.•Develop objectives, operating policies, products, processes and standards in support of the business strategy.•Communicate with internal and external customers and vendors concerning ongoing operations, programs or processes.•Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. •Oversee Quality Systems area of responsibility, communicate business and operational development, plan, prioritize and direct the responsibilities of direct reports. Mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s.•Initiate programs or projects based on identified business and tactical needs. •Develop objectives, operating policies, products, and processes in support of the business strategy. •Communicate with internal and external customers and vendors concerning ongoing operations, programs or processes.•Oversee FDA 510(k) approvals. Ensure regulatory compliance for US & OUS countries

Grafton, Wisconsin, United States

Responsible for Quality Assurance and the Quality Management system within the organization.Function as the Management Representative and the liaison with internal and external parties on all quality matters.Ensure the company's quality system is maintained in accordance with 21 CFR Part 820, and ISO 13485.Oversee and manage all quality personnel. Skills: Quality Management Systems · Risk Management · Corrective and Preventive Action (CAPA) · Personnel Management · Internal/External Audits · Management Representative · Validations · Quality Engineering

Germantown, Wisconsin, United States

Responsible for Quality Assurance within the organization.Function as the Management Representative and the liaison with internal and external parties on all quality matters.Ensure the company's quality system is maintained in accordance with 21 CFR Part 820, and ISO 13485.Oversee and manage all quality personnel. Responsible for Quality Assurance within the organization. Function as the Management Representative and the liaison with internal and external parties on all quality matters.