Tucson, AZ (campus most likely still remote through the end of the year)
Initial 3-month contract (w2 only)
This position is responsible for performing compliance activities with limited supervision, including but not limited to Post Launch Review (PLR) and IVDR Post market surveillancereporting. This position will work closely with the Regulatory Compliance and/or Quality Manager and multiple business areas to complete the PLRs and IVDR Post market surveillance. Responsibilities Assists with the maintenance of processes/procedures for ensuring compliance to internal and external requirements. Provides compliance support for manufacturing, R&D, Quality Assurance, and Operations as required to assure regulatory compliance and appropriate business planning. Supports communications with scientific and Regulatory bodies as necessary. Maintains regulatory compliance controlled document archives as directed. Constructs and distributes minutes associated with Post Launch review (PLR) and IVDR Post market surveillance meetings Works with management to help create and analyze trends from product performance. Creates required summary reports and processes them along with supporting data in the site's Document Control System. Resolves issues affecting report approval.
- Participates in, and where necessary, drives the continuous improvement of the quality processes.
- Knowledge of change control and document management systems
- Solid understanding of a quality system and its development, documentation and implementation with respect to domestic and international standards and requirements.
- Able to develop and implement quality programs, including tracking, analyzing, reporting and problem solving.
- Knowledge of word processing and spreadsheets.
- Solid understanding of problem solving and quality improvement tools and techniques, including management and planning tools, preventive and corrective actions, and how to overcome barriers to quality improvements.
- Solid understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
- Strong reasoning, interpersonal and organizational skills. Displaying a high degree of accuracy and quality.
- Ability to work in past paced setting and cross-functionally with all levels of employees.
- Excellent oral and written communication skills. Ability to prepare and present information to groups.
- High degree of initiative with the ability to work independently