Associate Director Field Assurance

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Under the leadership of the Sr. Director Quality Management System, the Assoc. Director Field Assurance will be responsible for the leadership and management of the Field Assurance resources and activities within the Quality Assurance function.

• →Responsible for the leadership and supervision of the complaint handling and medical device reporting processes across the Surgery Business Unit to ensure timeliness, consistency and compliance to internal standards/procedures and applicable external, industry regulations/standards.
• →Responsible for business unit and corporate-wide complaint handling central function continuous improvement initiatives.
• →Escalate significant events, trends, potential quality issue and personnel issues as needed to ensure actions are taken to address both operational and product performance quality issues.
• →Provide guidance and training to staff, drives organizational development, assists staff in attaining career goals and motivates individuals to achieve results.
• →Manage performance of staff and provide fair, accurate and timely feedback.
• →Manages and presents analysis of complaint handling operational and product performance in various management and post market surveillance reviews.
• →Provide complaint handling and regulatory reporting subject matter expertise in support of internal and external audit activities.
• →May serve as liaison between the company and various regulatory agencies (i.e. audits, additional information request inquiries, etc.)
• →Ensure personal and staff training is completed by established due dates.  Maintain staff training matrix.
• →Maintain and adhere to departmental processes and systems to ensure regulatory compliance.
• →Support and manage annual budget for the areas of responsibility.

• B.S. degree, Engineering, Science, Biology, Business Administration or equivalent degree. with advanced degree preferred.
• 5+ years related experience in managing complaint handling in the medical device, pharmaceutical or biotech industry.
• Supervisory/management experience.

• Strong working knowledge of medical device terminology as well as anatomical and physiological terminology.
• Strong working knowledge of medical device industry and regulatory requirements.
• Strong proficiency in common computer applications such as Microsoft Office (Excel, Word and Outlook).
• Excellent written and verbal communication, presentation, problem solving and applied thinking skills.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.