Senior Quality Engineer (Vernon Hills, IL)
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
The Senior Quality Engineer is responsible for supporting Design Quality Assurance within the V. Mueller 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.
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.
Performs Internal or Supplier Quality System Audits.
Ensures compliance to Department and Division procedures.
Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.
Performs Complaint review and investigation as required.
Tracks and trends Quality Indicators.
Collaborates with manufacturing facility or other Division Facilities.
Serves as Independent QA Reviewer and Chairperson for Design Reviews.
Education and/or Experience:
B.S in Engineering, Engineering Technology, Science a minimum.
Minimum 5 years of experience in a FDA regulated industry including 3 years on product development experience.
3 - 5 years Design Control and Risk Management experience with medical devices.
Experience operating in and auditing GMP, GLP.
Employment at BD is contingent upon the Company’s receipt of sufficient proof that you are or will be fully vaccinated against COVID-19. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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.
Primary Work LocationUSA IL - Vernon Hills
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Approbationdu Présiden et Chef de la direction
«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
Anonyme, Franklin Lakes, NJ