Plan, perform, support and document QMS and EMS compliance audits. These audits must be tracked to standards and regulations.
Manage the tracking of the corrective actions.
Support checklist maintenance and updates.
Contribute and supportinternal and external team Sharepoint sites.
Maintain compliance files.
Be a certified lead auditor.
Follow up on internal and external audit observations and actions.
Support and maintain recall log and files.
Develop tools to streamline audit consistency.
Update compliance team documents, as requested.
Support quality initiatives, goals, and metrics.
Assist and support customer and external audits, as requested.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Perform specialty audits, as requested by management.
Mentor compliance and quality team members:
Divisional compliance team practices and expectations
Performs other related duties and responsibilities, on occasion, as assigned.
Bachelor's degree or equivalent work experience
5+ years of experience in the systems quality discipline with extensive backend, integration project testing
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel up to 50%, including internationally.