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Global Quality Systems Specialist
hace 3 semanas
Join to apply for the Global Quality Systems Specialist role at Advanced Sterilization Products Location: Remote in the US, Canada, Mexico, Brazil, Colombia, Argentina The Global Quality Systems Specialist at Advanced Sterilization Products is responsible for executing global Quality System requirements. The position reports to the leadership of Quality Systems. Responsibilities Manage document revisions, ensuring compliance with formatting and approval workflows Coordinate change control documentation and facilitate cross‑functional review Analyze change orders to ensure compliance with GDP requirements and existing procedures Track and monitor quality systems metrics, including 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 Solve problems in straightforward situations; analyze possible solutions using technical experience and judgment and precedents Explain 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 Communicate business‑related issues or opportunities to next management level Support continuous improvement initiatives Perform other duties as assigned Qualifications 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 Experience and Education 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 Compensation Bonus or Equity : This position is also eligible for bonus as part of the total compensation package Pay Range : 70,600.00 - 117,900.00 (local currency) Seniority Level Not Applicable Employment Type Full‑time Job Function Quality Assurance Industries: Medical Equipment Manufacturing Equal Opportunity Employment 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 #J-18808-Ljbffr
