Global Quality Systems Specialist at Fortive

United States

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). Fortive Corporation Overview Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions. We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions. We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.  At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.  At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.  At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating. Fortive: For you, for us, for growth. About ASP  ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.   ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.  We Are an Equal Opportunity Employer   Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.