Position Summary

Reporting to the Senior Director, Global QMS, the Director, Customer Quality position will manage complaint handling activities ensuring that our teams meet quality, safety and compliance standards. This role will maintain, and continually improve a robust Supplier Quality Management System in support of ASP’s business strategy and objectives. Responsibilities also include leading a team of individuals through completion of reportability determinations, medical reviews and justifications as well as timely evaluation, investigation and closure of reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards.

The manager will also have overall responsibility for ensuring customer complaint investigation processes are compliant, effective, and efficient and that continuous improvement through corrective and preventive action processes are effectively implemented throughout the organization.

Duties and Responsibilities

Under limited supervision, general direction, etc. and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position will:

• Establish, lead, maintain and continuously improve all Quality activities associated with suppliers and contract services including finished goods, raw materials, components, manufacturing support services, and product distribution providers.

• Direct the standardization of Supplier Quality processes that drive Customer Quality efficiencies.

• Develop policies and requirements for Supplier Quality Management Systems to ensure compliance while minimizing product quality risk in order to expand business portfolio.

• Implement procedures for effective complaint processing, complaint investigation and supplier performance.

• Initiate Company Issue Escalation, CAPA, and Customer Response letters as needed.

• Evaluate Reportability Determination for US Medical Device Reports (MDRs) and Reports Required in Other Regions.

• Maintain Compliance to Applicable Foreign and Domestic Regulations Governing the Management and Processing of Medical Device Related Complaints including Protected Health Information (PHI) and Patient Privacy Laws.

• Implement appropriate metrics to track & monitor compliant management lifecycle to include but not limited to regulatory reporting, cycle time aging.

• Collaborate with the Field Service Engineering, Medical Affairs, manufacturing, and other departments to ensure complaint investigations are complete, thorough, timely and meet regulatory reporting requirements.

• Find opportunities to continually improve customer quality and supplier performance consistent with the Quality Business Objectives

• Collaborate with cross-functional teams to ensure quality considerations are integrated into all stages of the product lifecycle, from development through post-market surveillance.

• Provide oversight and direction for all quality-related risk management practices in an effort to proactively address potential threats to product quality and provide appropriate solutions that address business needs and are aligned with the Company’s core values.

• Drive continuous improvement metrics and scorecards to support supplier performance management.

• Continuously assess and refine quality assurance strategies in support of customer and supplier quality, ensuring adaptability and responsiveness to changing organizational and business needs.

• Be responsible for communicating business related issues or opportunities to next management level.

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.

The salary range for this position (in local currency) is 164,500.00 - 305,500.00. Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge; skills; experience; and other eligibility factors such as geographic location. The Total Rewards package includes competitive base pay and an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and several programs that provide for both paid and unpaid time away from work.

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.