Head of Customer Quality Assurance
2 weeks ago
Job Category:
Quality Assurance
QMS Impact Category:
Direct Oversight
Position Overview
Reporting directly to the Senior Director of Global Quality Management Systems, the Director of Customer Quality will oversee the management of complaint resolution processes, ensuring adherence to quality, safety, and compliance benchmarks.
This role is pivotal in maintaining and enhancing a comprehensive Supplier Quality Management System that aligns with Fortive Corporation's strategic objectives.
Key responsibilities include leading a dedicated team in the evaluation of reportability, conducting medical assessments, and ensuring timely investigation and resolution of both reportable and non-reportable product complaints in compliance with established protocols and global regulations.
Key Responsibilities:Under limited supervision and in accordance with all relevant laws, regulations, and company policies, this position will:
• Establish, lead, and continuously enhance all quality-related activities associated with suppliers and contract services, including finished goods, raw materials, components, and distribution services.
• Develop policies and requirements for Supplier Quality Management Systems to ensure compliance while mitigating product quality risks to broaden the business portfolio.
• Implement effective procedures for complaint processing, investigation, and supplier performance evaluation.• Initiate necessary Company Issue Escalation, Corrective and Preventive Actions (CAPA), and Customer Response communications.
• Assess Reportability Determination for Medical Device Reports (MDRs) and other regional reporting requirements.
• Ensure compliance with applicable domestic and international regulations governing the management and processing of medical device-related complaints, including Protected Health Information (PHI) and Patient Privacy Laws.
• Establish metrics to monitor and track the complaint management lifecycle, including regulatory reporting and cycle time aging.
• Collaborate with various departments such as Field Service Engineering, Medical Affairs, and Manufacturing to ensure thorough and timely complaint investigations that meet regulatory requirements.
• Identify opportunities for continuous improvement in customer quality and supplier performance in line with Quality Business Objectives.• Work with cross-functional teams to integrate quality considerations throughout all stages of the product lifecycle, from development to post-market surveillance.
• Provide oversight for all quality-related risk management practices to proactively address potential threats to product quality and deliver solutions that align with the company's core values.
• Drive metrics and scorecards to support supplier performance management.• Continuously evaluate and refine quality assurance strategies to support customer and supplier quality, ensuring adaptability to changing business needs.
• Communicate business-related issues or opportunities to the next management level.Other Responsibilities:
☐ N/A
Perform additional duties as assigned.
Qualifications:
• Bachelor's Degree required, preferably in Engineering, Business, Regulatory Affairs, or Operations Management.
Experience:
• Minimum of 7+ years of relevant business experience required, with a focus on Quality and Regulatory Compliance in the Medical Device sector.
Skills and Abilities:
• Ability to engage senior management in identifying critical needs and ensuring effective global deployment.
• Strong multitasking skills, with the ability to understand customer requirements and provide timely responses.
• Proven ability to prioritize and manage multiple responsibilities effectively.• Knowledge of Quality Management Systems (QMS), ISO 13485, and EU MDR standards.
• Excellent communication skills across all company levels, with the ability to convey complex ideas clearly to diverse audiences.
• Extensive knowledge of global quality assurance principles, practices, and methodologies, with a strong emphasis on Good Manufacturing Practices (GMP) and relevant regulatory standards.
Physical & Work Environment Requirements:• Travel on the Job: Up to 30% (Domestic and International)
• Standing: 10-20%
• Sitting: Up to 80%
• Additional requirements as necessary to perform essential job functions.
Environmental, Health and Safety Commitment:
All employees are expected to actively support Fortive's Environmental, Health and Safety (EHS) Policy by providing necessary resources and emphasizing safety alongside other functions.
This job description aims to convey essential information about the role and is not intended to be an exhaustive list of skills, duties, or working conditions associated with the position.
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