Global Quality Systems Specialist at Fortive in Remote, Remote

Job Summary:
Responsible to execute to the global Quality System requirements. This position reports to the leadership of Quality Systems.

Key Responsibilities:
- 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.
- Internal interaction with cross-functional team members including Global teams.
- Minimal interactions with Regulatory Health Authority.
- Communication with customers requesting Quality System profile information.

Education and Experience:
Bachelor’s Degree. 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.

Role and Competencies Requirements:
In-depth knowledge of QMS and regulatory requirements. 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. Travel: Domestic and International. Lifting Requirement: Light (0-15 lbs).

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