Sr. Quality Engineer, Software

Becton Dickinson Medical Devices • San Diego, CA

1d • Onsite

About The Position

We are the makers of possible. 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. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Description Summary: Core team quality representative for design control projects – new product development as well as sustaining efforts. Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; and regulatory and compliance support. Provide clarification and guidance to teams on overall quality system with emphasis in design controls. Review design artifacts to ensure compliance with QMS and good documentation practices prior to final approval. Work closely with program managers to ensure design deliverables are met and products can be commercially released in defined markets. Ensure effective verification and validation of design specifications and requirements. Review and ensure complete and comprehensive traceability of related design artifacts. Active participant in the development of product requirements, product system hazard analysis and design reviews. Work collaboratively to drive root cause analysis of failures and structured problem solving for product development and manufacturing issues. Ensure product technical files and Design History Files are complete and auditable. Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams.

Requirements

• Bachelor’s degree in Engineering (any), Information Technology, Information Systems, Computer Science or related field of study and three (3) years of experience in the job offered or related occupation in which the required experience was gained.
• Must have demonstrated experience with: Quality engineering policies, principles and best practices; regulatory and international standards requirements (21 CFR 820, ISO 13485, ISO 14971 and IEC 62304); Quality Engineering tools (Sampling Plans, Root Cause Analysis and Statistics); Corrective and Preventive Actions; Risk Management for Medical and Non-Medical Devices; Audits/Inspections; Software Verification and Validation; Software development within a regulated environment; software development methodologies; and Scaled Agile Framework [SAFe].

Responsibilities

• Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; and regulatory and compliance support.
• Provide clarification and guidance to teams on overall quality system with emphasis in design controls.
• Review design artifacts to ensure compliance with QMS and good documentation practices prior to final approval.
• Work closely with program managers to ensure design deliverables are met and products can be commercially released in defined markets.
• Ensure effective verification and validation of design specifications and requirements.
• Review and ensure complete and comprehensive traceability of related design artifacts.
• Active participant in the development of product requirements, product system hazard analysis and design reviews.
• Work collaboratively to drive root cause analysis of failures and structured problem solving for product development and manufacturing issues.
• Ensure product technical files and Design History Files are complete and auditable.
• Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams.

Benefits

• A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.
• It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
• At BD, you’ll discover a culture in which you can learn, grow, and thrive.
• At BD, you’ll discover a culture in which you can learn, grow and thrive.
• Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior