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BD (Becton, Dickinson and Company) Senior Quality Engineer (Remote Opportunity) in Vernon Hills, Illinois

Job Description Summary

Job Description

The Senior Quality Engineer is responsible for supporting Design Quality Assurance within the Infection Prevention Platform: Design Controls, Risk Management, Human Factors / Usability Engineering. The incumbent works multi-functionally with teams on new product design, design transfer, risk management, process/product design, quality improvement projects (QIPs) and cost to win (CTW) projects.

This position is also responsible for supporting Design Quality Assurance within the Infection Prevention Platform (new product design and development, design transfer, design validation, risk management.). The incumbent works closely with RD&E on new product development projects that will have significant impact on the business. The incumbent works closely with Regulatory Affairs, Designated Complaint Handling Unit (DCHU), Sterility Assurance, Packaging Technology Center, Manufacturing, Sales, Marketing, Operations, and Finance.

The Senior Quality Engineer interacts with Regulatory Affairs regarding new regulations and standards as they apply to new product development regulatory submissions, with DCHU 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 Senior Quality Engineer supports CAPA throughout the organization.

The Senior Quality Engineer reports directly to the Associate Director, Quality for the Infection Prevention Platform and maintains communication for assistance in resolving quality initiatives/projects and executing design, development, and design transfer initiatives.

Primary Responsibilities:

  • Design Assurance: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 projects/initiatives, in accordance with FDA (21CFR§4, 21CFR§210 and 211 and 21CFR§820), ISO 13485, CMDR, EU MDR, J-PAL and ISO 14971.

  • Design risk management: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.

Education/Skills/Requirements:

  • Bachelor's degree in Engineering or Chemistry from an accredited four (4) year university.

  • 3 - 5 years Design Control and Risk Management experience with medical devices.

  • Knowledge of combination products.

  • Experience operating in and auditing GMP, GLP.

  • Knowledge of statistics and DOE

  • Attentiveness to details with strong organizational skills.

  • Ability to work proactively and independently.

  • Ability to multi-task and efficient in time management.

  • Excellent verbal communication and interpersonal skills

  • Ability to work in a team environment.

  • Proficiency in Excel, Word, and other desktop/general business systems.

  • Approximately 15 - 20% travel may be 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, or any other protected status.

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Primary Work LocationUSA IL - Vernon Hills

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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, or any other protected status.

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