Sr Quality Engineer II

Becton Dickinson Medical Devices•San Diego, CA

7d•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: Assist with all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support. Actively reviews design artifacts to ensure compliance with QMS and good documentation practices prior to final approval. Ensures effective verification and validation of design specifications and requirements. Complete traceability of related design artifacts. Support in the development of product requirement, 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.

Requirements

Master’s degree in Industrial, Mechanical or Manufacturing Engineering and three (3) years of experience in the job offered or related occupation in which the required experience was gained.
Demonstrated experience in Regulatory and international standards requirements including 21 CFR 820, ISO 13485, ISO 14971 and IEC 62304 to support quality engineering activities.
Demonstrated experience in Application of Software Quality Concepts specifically ensuring compliance with Software Development LifeCycle (SDLC) per IEC 62304.
Demonstrated experience in Development and maintenance of multi-directional traceability matrices from user needs, product requirements to design specifications, risk controls, and design verification.
Demonstrated experience in Quality Engineering tools such as: Root Cause Analysis, Design of Experiments and Statistical Analysis).
Demonstrated experience in Quality Audit Management (Internal and External) - performing internal audits and representing the QMS during external notified body audits.
Demonstrated experience in Medical Device Defect review and tracking - Risk based defect triage and disposition aligning post-production issues with hazard analysis and clinical impact.
Demonstrated experience in Corrective and Preventive Action (CAPA).
Demonstrated experience in Engineering Design Change Management and DHF Management for Medical Devices.
Demonstrated experience in Safety-Critical Hazard Analysis and Risk Management.
Demonstrated experience in Customer complaints, Medical Device Reporting (MDR) assessments, and post market non-conformance reporting.

Responsibilities

Assist with all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.
Actively reviews design artifacts to ensure compliance with QMS and good documentation practices prior to final approval.
Ensures effective verification and validation of design specifications and requirements.
Complete traceability of related design artifacts.
Support in the development of product requirement, 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.

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.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture.
Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program.
We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.
Our salary or hourly rate ranges reward associates fairly and competitively.
We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully.
The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location.
Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.