This person maintains, plans, coordinates, and conducts Corporate Quality Compliance for the internal auditing program and quality management system. This person is responsible for the internal audit process to meet the requirements of internal procedures and external regulations and providing support during external inspections.
Essential Duties and Responsibilities:
- Create,audit/review, and implement the Corporate Quality Management System (QMS).
- Maintains Corporate QMS in compliance with U.S. Food and Drug Administration (FDA) regulations, other country regulatory requirements (Europe, Canada, Japan, Brazil, Australia, and additional countries).
- Support Divisional initiatives as identified by divisional management and in support of the Corporate QMS, OUS Environmental Regulation Compliance, and other regulatory requirements.
- Support and coordinate product recall activities including documentation, activity management, tracking and trending analysis, and interface with government officials.
- Plan, coordinate, and conduct Corporate Quality ComplianceInternalaudits.
- Provides training or training opportunities for internal auditors.
- Trends internal audit data.
- Create, coordinate, and monitor corrective action activity for internal audit nonconformances and concerns.
- May conduct internal audits
- Supports external andinternalaudits/inspections and continuing certification
- Create, coordinate, and monitor corrective action activity for audit nonconformances and concerns.
- Tracks external auditschedules.
- Confirms the filing of pertinent documentation from external audits.
- Provides support to facilities during inspections/audits.
- Support and coordinate Corporate Management Review activities including documentation and activity management.
- Complies with FDA regulations,othercountry regulatory requirements (Europe, Canada, Japan, Brazil, Australia, and additional countries), company policies, operating procedures, processes, and task assignments.
- Maintains cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors to maintain the Corporate Quality System.
- Performs other related duties and responsibilities, on occasion, as assigned
- 2 years auditing per ISO and/or FDA standards, including direct involvement with external regulatory audits.
- Strong writing and verbal communications skills with ability to effectively communicate at multiple levels in the organization.
- Knowledge of the following regulation areas as they pertain to quality systems and product recall processes: QSR, ISO, MDD/MDR, MDSAP
- Lead Auditor Certification for ISO 13485.
- Experience working in a broader enterprise/cross division business unit model preferred.
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
- Ability to work effectively within a team in a fast-paced changing environment.
- Ability to maintain regular and predictable attendance.
- With a BS/BA degree: minimum of 10 years’ experience in the medical device industry and 2 years auditing per ISO and/or FDA standards, including direct involvement with external regulatory audits. Experience may substitute for degree.