Position Summary

This position ensures development and implementation of quality systems in compliance with established standards and support local region. The individual will interact with and provide oversight to local operating companies to ensure adherence to the ASP quality management system and local/in country regulations.

Duties and Responsibilities

• Implements and supports ASP Quality Management System and its integrated programs within the respective region, such as quality systems training, internal audits, nonconformances, corrective and preventive action, records management, field actions, supplier quality management, procurement, servicing, distribution, and post market surveillance.

• Assures compliance with applicable regulations such as, but not limited to, ISO 13485, EU MD Directive/Regulations, China GSP & GMP.

• Maintains, sustains and continuously improves the Quality Management System and monitors the performance and health of the Quality Management System through metrics and analytics.

• Oversees quality operations activities performed by contract manufacturer under MAH regulations.

• Maintains quality oversight of local distribution and warehouse management process (assessment, qualification, monitoring).

• Perform commercial release of China made medical devices.

• Supports local supplier/vendor selection, qualification, and audits.

• Ensures timely investigation of nonconformances.

• Establish corrective and preventive actions to mitigate potential or actual noncompliance risks.

• Assesses product quality issues and escalates to upper management through established processes.

• Ensures timely post-market surveillance & vigilance (Field Actions and Product Complaints) management

• Ensures timely and consistent escalation of events.

• Support market quality compliance activities as required by the direct manager and in collaboration with associates.

• Collaborate cross-functionally to support projects assigned by the direct manager.

Qualifications

• Bachelor’s Degree

• Minimum of 5 years of experience in medical device industry in the areas of Quality, Manufacturing, or related field.

• Demonstrated knowledge of regulatory standards and regulations, such as, but not limited to, China GSP & GMP, MAH regulations, ISO 13485, ISO 14971.

• Ability to work and communicate in a cross-cultural environment

• Excellent communication skills both written and verbal

• Highly developed influence, interpersonal, communication and conflict resolution skills

• Ability to interact with all levels and disciplines within the organization

• High sense of urgency, adaptable to meet rapidly changing priorities

• Proven analytical/quantitative skills

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.

Fortive: For you, for us, for growth.

This position is also eligible for bonus as part of the total compensation package.

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.