Global Quality Systems Specialist
Manages document revisions, ensures compliance with formatting and approval workflows Coordinate change control documentation and facilitate cross functional review. Analyzes change orders to ensure compliance to GDP requirements and existing procedures. Track and monitor quality systems metrics, including but not limited to: IE, CAPA and NC Support timely documentation and closure Assist in quality planning activities and QMS review preparation. Manage training assignments and monitor training metrics Participate in internal audits and support audit readiness activities. Support internal audit logistics such as scheduling Provide informal guidance to new team members. Solves problems in straightforward situations; analyzes possible solutions using technical experience and judgment and precedents Explains complex information to others in straightforward situations Collaborate with cross-functional teams to resolve issues. Collaborate cross functionally to support projects as assigned by direct manager. Responsible for communicating business related issues or opportunities to next management level. Supports continuous improvement initiatives Perform other duties as assigned. Working knowledge of quality management systems and experience with ISO 13485. Excellent written and verbal communication skills (English) Demonstrated ability to train, mentor, and coordinate the work of others in daily operations Seeks to deeply understand customer needs and prioritize work accordingly Willing to take on the unknown and overcome adversity to support the goals of the business Seeks varied perspectives and experiments with new ways of solving problems Collaborates in support on team's success Demonstrates urgency and ownership to consistently deliver on objectives using FBS Bachelor's degree in engineering, science, or related field. Minimum 3 years of experience in a quality or regulatory role in medical devices or related regulated industry. Equivalent combination of education and experience will be considered.
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Global Quality Systems Specialist
Manages document revisions, ensures compliance with formatting and approval workflows Coordinate change control documentation and facilitate cross functional review. Analyzes change orders to ensure compliance to GDP requirements and existing procedures. Track and monitor quality systems metrics, including but not limited to: IE, CAPA and NC Support timely documentation and closure Assist in quality planning activities and QMS review preparation. Manage training assignments and monitor training metrics Participate in internal audits and support audit readiness activities. Support internal audit logistics such as scheduling Provide informal guidance to new team members. Solves problems in straightforward situations; analyzes possible solutions using technical experience and judgment and precedents Explains complex information to others in straightforward situations Collaborate with cross-functional teams to resolve issues. Collaborate cross functionally to support projects as assigned by direct manager. Responsible for communicating business related issues or opportunities to next management level. Supports continuous improvement initiatives Perform other duties as assigned. Working knowledge of quality management systems and experience with ISO 13485. Excellent written and verbal communication skills (English) Demonstrated ability to train, mentor, and coordinate the work of others in daily operations Seeks to deeply understand customer needs and prioritize work accordingly Willing to take on the unknown and overcome adversity to support the goals of the business Seeks varied perspectives and experiments with new ways of solving problems Collaborates in support on team's success Demonstrates urgency and ownership to consistently deliver on objectives using FBS Bachelor's degree in engineering, science, or related field. Minimum 3 years of experience in a quality or regulatory role in medical devices or related regulated industry. Equivalent combination of education and experience will be considered.