This person is responsible for assuring that the quality policy and quality system are understood, effectively implemented, and maintained at all levels of the organization.
Develop and refine QMS documents by developing procedures, guidance documents, forms, training materials, and other documentation
Ensure QMS processes are compliant with pertinent regulations and external standards
Maintain a working knowledge of QMS procedures, regulations, and standards
Train staff on QMS processes
Ensure compliance to Quality Management System (QMS) processes
Interact with colleagues at all levels with the goal of researching, problem-solving and coordinating QMS activities to ensure the quality system is effectively implemented
Perform QA and QC responsibilities outlined in the QMS (e.g., review and approve protocols, reports, project documentation, validation documentation, and regulatory submissions for accuracy and compliance to applicable procedural standards and work instructions)
Assess impact of proposed procedural changes to QMS and other QMS documents
Assist with the performance of internal, external and supplier audits throughout the entire audit lifecycle
Technically qualified by education, training and/or experience
Minimum of B.S. degree, preferably in engineering or science, 3 years of relevant medical device quality system experience preferred or a combination of education and experience
Ability to work effectively within a team and discern how the quality system can help staff reach project goals; understand the goals of Quality System users
Excellent communication skills to communicate effectively with professionals from a wide range of backgrounds and education levels
Computer skills including word processing and spreadsheets
Ability to present information in a professional manner
Conscientious person with good work ethic
Able to work independently or in a group environment
Ability to work with multiple persons, changing priorities and fluctuations in work load
Excellent organizational skills and prioritizing skills
Experienced or trained in auditing techniques, including successful completion of an internal auditing course
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