Becton Dickinson

Design Quality Engineer III

USA CA - San Diego Bldg A&B, USA · Mid

Sponsorship not specified$106k-$169kDetected 15 days ago

FDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingRegulatory Affairs

About the role

Participate in design control activities, including design reviews, risk management, and verification and validation planning and execution.
Support the development and maintenance of design and development files (DDFs) to ensure compliance with internal procedures and external regulations (e.g., FDA, ISO 13485).
Mentor junior quality engineers and provide technical guidance on design quality principles and practices.
Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, Marketing) to ensure quality objectives are met.
Develop and implement quality plans, procedures, and work instructions to enhance the effectiveness of the quality management system.
Provide quality engineering support for CAPA activities, including performing investigations and implementation of actions, and executing verification of effectiveness (VOE) to ensure solutions are sustained and compliant with FDA/ISO and internal requirements.

Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Industrial, or related field)
Strong working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485
Hands-on experience with design controls and risk management (ISO 14971)
Strong analytical and problem-solving skills with the ability to investigate complex issues
Ability to work both independently and collaboratively in a fast-paced environment
You can learn more on our career site under " Our Commitment to You."
5-7 years of experience in Design Quality Engineering within the medical device industry
Basic understanding of corrections/removals processes (21 CFR Part 806)
Effective written and verbal communication skills

Master's degree in Engineering
Experience with statistical software (e.g., Minitab, JMP)
ASQ certification (CQE, CRE, CMQ/OE)
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.
At BD, you'll discover a culture in which you can learn, grow and thrive.
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 orientatio

This listing is sourced directly from Becton Dickinson's careers page and normalized into a canonical job model.