Terumo Medical Corporation QA Auditor in Sunrise, Florida
Monitors and reports results of the Quality Management System compliance of the company and in providing guidance for the organization team on matters relating to compliance. As a quality auditor this position performs periodic documented examination and verification of activities, records and processes of quality system from all the regulatory bodies associated with the company, in order to determine the effectiveness and dependability of such system. As an auditor he/she monitors all quality standards for the manufacturing activities and support activities.
Maintains, and revises policies and procedures for the general operation of the Quality Management Systems compliance program and its related activities to prevent non-conformances.
Manages day-to-day operation of the program including internal and external audits.
Collaborates with other departments (e.g., Research and Development, Manufacturing, Operations, Purchasing, Quality, etc.) to direct compliance issues to appropriate existing channels for investigation and resolution. Consults with other members of the team as needed to resolve difficult compliance issues.
Acts as an independent review and evaluation body to ensure that compliance Issues/concerns within the organization are being appropriately evaluated, investigated and resolved.
Monitors, and as necessary, coordinates compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends.
Identifies potential areas of compliance vulnerability and risk; propose the necessary corrective action plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future.
Monitors the performance of the Quality Management System compliance program and related activities on a continuing basis, taking appropriate steps to improve its effectiveness.
Maintains training to current regulations used to perform internal and supplier quality system audits.
Other duties as assigned.
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Minimum Skills and Capabilities:
Excellent Written and Verbal Communication
Understanding of quality system regulations (ISO13485, 21CFR820) and any other international regulations, as applicable
Ability to interact with all levels within organization
Analytical skills for compiling and analyzing data
Computer and software skills
Ability to motivate others and improve efficiency
Minimum Knowledge & Experience required for the position:
Bachelor’s degree in a technical discipline, or equivalent experience
At least a minimum of 2 years’ experience in medical device quality assurance and/or regulatory affairs roles.
Affirmative Action/Equal Employment Opportunity Statement
It is the Company's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. In compliance with the Americans with Disabilities Act (ADA), if you have a disability and would like to request an accommodation with regard to the application and selection processes (for example, the online application process or interviews) or have any questions about our website accessibility, please call 732-302-4902 or e-mail us at Staffing@Terumomedical.com.
Terumo Medical Corporation
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