- Coordinate the reporting, analysis, and resolution of material non-conformance incidences. Participate in Material Review Board meetings, as needed.
- Develop quality assurance specifications, test methods, sampling plans and related written procedures.
- Facilitate the launching of new or improved products/processes, and the transfer of technology from development to commercialization from a Quality and manufacturing perspective.
- Write and coordinate efforts for the development and implementation of new and updated Quality System procedures such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development and task force projects.
- Coordinate the identification, assignment, monitoring, and completion of product improvement projects in cross-functional teams.
- Conduct statistical analysis (F-test, t-test, ANOVA, normality tests, etc) and generate trend reports for projects on an as-needed basis.
- Utilize Quality Engineering tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, conduct process and systems audits and to assist in specification development.
- Conduct quality audits and develop subsequent preventive action programs.
- Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Document Control, Clinical, Regulatory, and Research and Development functions.
- Conduct returned product analysis investigations and DHR review. Perform trending on complaint rates and provide feedback to management team.
BioSpace.com - 3 years ago