MidFull TimeEN
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.
Responsibilities:
Works with various departments to support SAP ACR/ECR/ECO implementation process throughout the organization
Works within and across functions to support the Change Control process throughout the organization.
Performing tasks, of moderate complexity, within planned schedules and timelines, supporting audits, actively leading or participating on project teams, ensuring change control documentation compliance
Follows applicable Company / Unit procedures and may make updates to procedures and policies.
Collaborate with QA resources to ensure compliance to FDA and Foreign Regulatory Agencies
Engineering Change Order Administrator reviewing and implementing ECR/O strategies for all SAP implementations ensuring all changes are compliant and executed on a timely manner.
Change leader and Regulatory liaison ensuring changes meet necessary compliance.
Manage Change Control Review Board making sure all changes are reviewed by the board
Deviation Administrator managing all deviations including the review board meetings and making sure all deviations are compliant.
Follow up for deviation administration such as on-time closure or extensions to remain in compliance.
Manage Monthly Quality Metrics required for compliance to local procedure.
Maintain constant communication with EU Quality team for any information required by the Qualified Persons along with continuous monthly change control reporting.
Follow up for approval and implementation of corrective actions for CAPA, External and Internal Audits findings, Customer Complaints, Quality Notifications, and Deviations.
Assist in internal and external audits.
Coordinate and compile APR (Annual Product Review) and PQR (Product Quality Review) reports for domestic and international product codes.
Assist with the Post NDA Annual Report.
Assist with the technical submissions used for international regulatory agencies.
Education:
Typically requires a minimum of a bachelor’s degree
4 years relevant experience or a combination of equivalent education and relevant experience.
Knowledge and Skills:
Moderate level of application of Quality system standards to assigned Quality system area.
Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements.
Computer proficiency in Microsoft office (Word, Excel, Power Point, Project, Outlook).
Good team player skills.
Bilingual preferred - English, Spanish
Experience in FDA, GMPs and ISO requirements.
Experience with SAP preferred.
Experience in Lean/Six Sigma preferred.
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.
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.
Required Skills
Optional Skills
.
