US, US, TN - Memphis
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 50%
Location: TN - Memphis
Work with overseas subsidiaries and internal Quality team on:
Comprehensive understanding and experience of QSR, ISO 13485:2016, MDSAP, and any other applicable regulatory standards.
Develop and execute project plan for global validation and asset management activities.
Develop validation master plans, validation protocols, summary reports, deviations, process flow diagrams, test cases, and standard operating procedures/work instructions as applicable.
Author and execute, IQ, OPQ.
Prepare validation or performance qualification protocols for new or modified processes, systems, and other types of production.
Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
Lead periodic review of equipment and critical utilities.
Lead cleaning validation and annual monitoring projects.
Conduct audits of validation or performance qualification processes to ensure compliance with internal and regulatory requirements.
Manage projects in a matrix organization as a team leader.
Author and execute validation protocols and summary reports for equipment qualifications, process and packaging validation, and cleaning validation processes to ensure regulatory agency compliance.
Support validation life cycle activities by commissioning, continuous process monitoring, change controls, SOP generation, and revalidation activities.
Support and lead special projects and serve as a quality liaison to operations.
Support regulatory and internal audits, for both domestic and international markets.
Travel 25% international and domestic.
Perform duties in compliance with applicable FDA, state, and global regulations as well as standards including, but not limited to, ISO 13485.
Work independently with minimal supervision to attain project goals and meet timelines.
Prior experience in development and implementation of validation plans. Demonstrated project management in Medical Device industry.
Requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience.
Manufacturing experience working in medical/aeronautical industry is helpful.