Senior Quality Specialist

Job Responsibilities

• Develops and implements QMS integration plans.
• Collaborates with stakeholders to execute QMS integration plans in line with business priorities.
• Executes integration-related activities such as labeling changes, procedure updates, and training updates.
• Aids in NB, Corporate, and other regulatory, external, and internal audit readiness.
• Supports internal and/or external audits.
• Applies quality and/or standard-setting body requirements to develop solutions, control, and maintain technical documents and/or Quality Systems.
• Trains, develops, and provides technical guidance to other associates.
• Participates in quality guidance and helps project & quality network teams for process improvement, standardization initiatives, and continuous improvement activities.
• Completes projects/other duties as assigned.

Education And Experience

Requires a bachelor's degree in an Engineering or relevant Scientific discipline, or a combination of equivalent education and relevant experience with a minimum of 5 years.

Knowledge And Skills

• In-depth understanding of US and International regulations and standards that apply to the medical device industry, including FDA Quality Systems Regulations, ISO 13485, IVDD, EU IVDR, Canadian MDR, Japan PMDA as well as ANVISA and TGA requirements.
• Experience supporting internal and/or external audits.
• Proficient with electronic document and change management systems.
• Exceptional attention to detail and strong project management skills.
• Excellent technical writing and communication skills.
• Ability to set and deliver to specific goals and targets.
• Effective analytical, technical, and problem-solving skills.
• Effective meeting and presentation skills.
• Ability to manage conflict.
• Self-motivated/directed.

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.

To learn more about BD visit https://bd.com/careers.

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.