Director of Customer Quality

Job Category : Quality

Quality

QMS Impact Category : Direct

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.

Other Duties : N / A

N / A

Performs other duties assigned as needed.

Qualifications

Education :

High School or Equivalent

Associate’s Degree

Bachelor’s Degree

Master’s Degree

PhD Degree

Bachelor’s Degree required, preferably in Engineering, Business, Regulatory, or Operations Management.

Years of Related Experience :

Minimum of 7+ years of business experience is required. Experience in Quality and Regulatory Compliance in Medical Devices.

Knowledge, Skills, Abilities, Certifications / Licenses, and Affiliations :

Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)

• Ability to engage senior management in identifying critical needs and to ensure effective deployment globally.
• Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.

Employee must be able to effectively prioritize and manage multiple activities and responsibilities.

• Knowledge of QMS, ISO 13485, EU MDR
• Proven track record to work remotely and partner globally required.
• Ability to communicate clearly and concisely across all levels of the company.
• Ability to cultivate an effective multi-functional, cross region, cross company team environment required.
• Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details is required.
• Extensive knowledge of global quality assurance principles, practices, and methodologies, with a strong emphasis on GMPs, the Fortive Business System and other relevant regulatory standards.

Responsibility for Others and Internal Interactions N / A

Senior / Staff Quality Engineers

External Interactions N / A Position requires interactions with External Manufacturers and suppliers. May interact with government agencies and Notified Bodies (i.

e., FDA, TUV) as required. Physical & Work Environment Requirements Physical Requirements : The physical demands identified are representative of the physical requirements necessary for an employee to successfully perform the essential functions of this job.

Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of this job.

While performing the responsibilities of this job, the employee may be required to talk and hear. Work Environment (mark all that apply) Travel on the Job : Up to 30% Domestic International

Scheduled Work Hours

Shift Work

On Call (Call in for Work) Approximate Position Requirements

Standing : 10-20%

Kneeling : 0%

Sitting : Up to 80%

Walking : 0%

Additional Work Environment Requirements N / A None Environmental, Health and Safety

All managers and employees shall proactively support ASP’s Environmental, Health and Safety (EHS) Policy by providing the necessary resources and giving equal emphasis with other functions such as production and quality.

It is the duty of every manager and employee to :

Ensure implementation of safety and environmental procedures, guidelines and standards.

Evaluate employee compliance and enforce established safety and environmental procedures and rules.

Create a safe work area environment, recognize safe activities, and reward good safety performance.

Provide training to employees when :

• Hired
• Transferred
• New substances, processes, procedures or equipment are introduced to the workplace and represent a new hazard

Measure safety performance and hold persons accountable for activities and results.

Ensure that incidents are investigated to determine root cause, and that corrective actions are taken.

Ensure employees wear required protective equipment.

Ensure EHS inspections are conducted monthly and corrective actions are implemented.

Occupational Hazards

Ergonomic Risk : Low Reproductive Health Risk : No Concern

Machine Operation

Electrical Hazards

Laser Hazards

Excessive Noise (>

85 dB)

Heights (>

6ft)

Hazardous Chemicals / Fumes

Excessive Dust

Bloodborne Pathogen

Biohazards (BBP and parts of LAH)

Extreme Heat / Cold

Other Hazards : Click or tap here to enter text. Powered Industrial Vehicles (PIV) Operation

N / A

Forklift

Motorized Pallet Jack

Company Vehicle

Lifting Requirement

N / A

Choose an item.

Ground to knees

Ground to Waist

Ground to Shoulders

Ground to Overhead

Waist to Shoulders

Waist to Overhead

Repetitive Hand Motions N / A

Twisting Motion

Computer Entry

Simple Grasp

Fine Manipulation

Additional Environmental, Health and Safety N / A None

Compliance

All employees have a duty to comply with applicable laws, regulations, standards, ASP policies and procedures.

This job description is intended to convey information essential to understanding the scope of this position and it is not intended to be an exhaustive list of skills, efforts, duties, responsibilities or working conditions associated with the position.

Employees are required to follow any other job-related instructions and perform job-related duties as may be reasonably assigned by his / her supervisor.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties of the job.

Signatures

The signatures below represent that the signers have read and understand the duties and responsibilities associated with this job description.

A scanned copy of the signed document is uploaded into the Document Management System.

Employee Printed Name Employee Signature Date Manager Printed Name Manager Signature Date

Submit your CV and any additional required information after you have read this description by clicking on the application button.

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.

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