Associate Director Field Assurance

7109 Davol, Inc.; Warwick (RI); In loco; USD 130.000 - 210.000; Tempo pieno

Descrizione del lavoro

Becton, Dickinson and Company is seeking a senior leader to direct Field Assurance within its Quality Assurance function. You will oversee complaint handling, medical device reporting, and regulatory compliance across the Surgery Business Unit, guiding staff and driving continuous improvement.

The role requires strong leadership, deep knowledge of medical device regulations, and a track record of managing complex quality programs.

Competenze

• B.S. degree in Engineering, Science, Biology, Business Administration or equivalent degree; advanced degree preferred.
• 5+ years in managing complaint handling in medical device, pharmaceutical or biotech industries; supervisory/management experience.

Mansioni

• Lead and manage Field Assurance resources and activities within Quality Assurance.
• Oversee complaint handling and medical device reporting across the Surgery Business Unit for timeliness, consistency and regulatory compliance.
• Escalate significant events, trends, or personnel issues to ensure actions address quality issues.
• Provide guidance, training and performance feedback to staff; drive organizational development.
• Prepare analyses of complaint handling and product performance for reviews and audits.
• Serve as liaison with regulatory agencies as needed.
• Ensure staff training and training matrix are up to date, and manage annual departmental budget.

Conoscenze

Medical device terminology

Regulatory knowledge

MS Office

Communication

Presentation skills

Problem solving

Formazione

B.S. degree in Engineering/Science/Biology/Business

Advanced degree preferred

Strumenti

Microsoft Office (Excel, Word, Outlook)

Descrizione del lavoro

We are the people who give possibilities purpose 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.

Job Description

Job Responsibilities

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.

Education and Experience

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.

Knowledge and Skills

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.

Why Join Us

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills Optional Skills

Primary Work Location USA RI - Warwick Additional Locations Work Shift We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.

Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.