The incumbent is responsible for supporting Design Quality Assurance within the Infection Prevention Platform (i.e., new product design and development, design transfer, design validation, risk management, etc.). The incumbent works closely with R&D regarding product quality planning that will have significant impact on the business. The incumbent maintains communication with the Unit Quality Manager for the Infection Prevention Platform, for assistance in resolving major quality initiatives/projects and executing design, development and design transfer initiatives.
The incumbent works closely with Corporate shared functions (e.g., Regulatory Affairs, Complaint Management, Sterility Assurance, Packaging Technology Center, etc.), as well as R&D, Manufacturing, Sales, Marketing, Operations, and Finance. The incumbent interacts with Regulatory Affairs regarding new regulations and standards as they apply to new product development regulatory submissions, with Complaint Management on complaint handling/resolution and field actions pre-/post - product launch, Packaging Technology Center on new product packaging projects, Sterility Assurance on sterilization process (re)validations and with Platform Management regarding product new design and development, as well as design transfer activities.The incumbent works with various departments and supports CAPA throughout the organization.
The incumbent reports directly to the Unit Quality Manager for the Infection Prevention Platform. The incumbent works cross-functionally with teams on matters related to new product design, design transfer, risk management, process/product design, quality improvement projects (QIPs) and product quality planning.
- Design Assurance:Quality Planning (i.e. new product development, design excellence and design transfer).
- Design and development planning, design input, design output, design review, design verification, design validation, design changes and design history file maintenance.
- Regulatory compliance:Regulatory compliance projects/initiatives, as assigned, in accordance with FDA (21CFR§4, 21CFR§210 and 211 and 21CFR§820), ISO13485:2016, CMDR, MDD, J-PAL and ISO 14971:2012.
- Design riskmanagement:Assure that appropriate risk management tools (i.e., SHAs, FMEA's) are utilized for all programs and projects and that the tools used are consistent with applicable regulatory standards and industry practices.
- Supplier audits:Evaluation of new suppliers to support design and development and to drive supplier improvement efforts.
- CAPA:Supporting corrective and preventive actions to problems/issues relating to process and/or product quality, such as complaint resolution, customer interface, and regulatory action.
- Bachelor's degree in a relevant degree field: Engineering or Chemistry from an accredited four (4) year university.
- Minimum 5 years of quality assurance/engineering experience
- Design Control and Risk Management experience with medical devices.
- Pharmaceutical background and knowledge of combination products.
- Experience operating in and auditing GLP, GMP and GCP.
- Knowledge of statistics and DOE, preferred.
- Attentiveness to details with strong organizational skills.
- Ability to work proactively and independently.
- Efficient in time management.
- Excellent verbal communication and interpersonal skills, with the ability to work in a team environment.
- Proficiency in Excel, Word, and other desktop/general business systems.
- Approximately 10 - 15% travel is required.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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