Associate Director Field Assurance

Becton Dickinson Medical Devices•Warwick, RI

5d•Onsite

About The Position

The Associate Director Field Assurance leads and manages Field Assurance resources and activities within the Quality Assurance function under the leadership of the Senior Director of Quality Management System. The role oversees complaint handling and medical device reporting across the Surgery Business Unit, ensuring timely, consistent, compliant processes. It also leads business-unit and company-wide continuous improvement initiatives for complaint handling. The Associate Director escalates significant events, trends, potential quality issues, and personnel issues; guides and trains staff; supports organizational development and career growth; and manages staff performance and feedback. The role analyzes and presents complaint-handling operations and product-performance information in management and post-market surveillance reviews, provides subject matter expertise for audits, and may liaise with regulatory agencies. Additional responsibilities include ensuring training completion, maintaining the staff training matrix, maintaining compliant departmental processes and systems, and supporting and managing the budget for areas of responsibility. BD prioritizes on-site collaboration. Most roles require at least four days per week in the office; the posting does not identify this role as remote or field-based. Employment may be contingent on providing sufficient proof of COVID-19 vaccination, subject to applicable accommodations and local requirements.

Requirements

Bachelor of Science degree in Engineering, Science, Biology, Business Administration, or an equivalent degree.
At least 5 years of related experience managing complaint handling in the medical device, pharmaceutical, or biotechnology industry.
Supervisory or management experience.
Strong working knowledge of medical device terminology and anatomical and physiological terminology.
Strong working knowledge of the medical device industry and regulatory requirements.
Strong proficiency with common computer applications, including Microsoft Excel, Word, and Outlook.
Excellent written and verbal communication, presentation, problem-solving, and applied-thinking skills.

Nice To Haves

An advanced degree.

Responsibilities

Lead and manage Field Assurance resources and activities within the Quality Assurance function.
Lead and supervise complaint handling and medical device reporting across the Surgery Business Unit, ensuring timeliness, consistency, and compliance with internal procedures and applicable external regulations and standards.
Lead business-unit and company-wide complaint-handling continuous improvement initiatives.
Escalate significant events, trends, potential quality issues, and personnel issues as needed.
Provide staff guidance and training, support organizational development and career goals, and motivate staff to achieve results.
Manage staff performance and provide fair, accurate, and timely feedback.
Manage and present analyses of complaint-handling operations and product performance in management and post-market surveillance reviews.
Provide complaint-handling and regulatory-reporting expertise for internal and external audits.
May serve as a liaison between the company and regulatory agencies, including for audits and additional-information requests.
Ensure personal and staff training is completed by established due dates and maintain the staff training matrix.
Maintain and follow departmental processes and systems to ensure regulatory compliance.
Support and manage the annual budget for areas of responsibility.