Sr. Quality Engineer, EMI, Quality Excellence

Becton Dickinson Medical Devices•San Diego, CA

2d•Onsite

About The Position

Job Description Summary The Sr. Quality Engineer, EMI, Quality Excellence, is responsible for ensuring compliance with the BD MMS Quality Management System. This role involves active participation in audit programs (both internal and external) and collaborating with plants and leadership within the EMI hub. This role is responsible for managing metrics and creating dynamic dashboards to support Operations Quality and Service Quality. This role is multidisciplinary focused on elements of quality system pertaining to analysis and improvement, data management, computer system validation, installation and servicing, decontamination, and complaint management. This role ensures robust quality systems and continuous improvement across all QMS processes to support BD EMI Quality Excellence. Job Description 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.

Requirements

Bachelor's degree in Engineering/Scientific discipline (Electrical, Mechanical, Bio-Medical, etc.) required.
Minimum four years experience in medical device.
Knowledge and experience in data trending, analysis and improvement, data management, computer system validation, installation and servicing, decontamination, and complaint management.
Expert knowledge in building dynamic Dashboards for metrics reporting
Ability to work independently in a fast-paced setting.
Proficient in MS Office, especially Excel; adept at mathematical applications like algebra, geometry, trigonometry, and statistics.
Strong organizational and attention to detail skills.
Excellent interpersonal and communication skills.

Nice To Haves

Preferred certifications include Total Quality Management, Six Sigma, or similar.

Responsibilities

Demonstrates expertise in FDA, ISO, and ANSI regulations and standards (For Ex: ISO 9001, ISO 13485, ISO 17025, 21 CFR Part 820, QMSR).
Creates necessary procedures and forms to support the Quality Management system.
Participates in internal, external, and 3rd party quality audits.
Owns, tracks and follows up on corrective actions (CAPA).
Collaborates on Corrective and Preventive Actions and process improvement projects.
Lead continuous improvement activities across the EMI hub and serve as an EMI SME for elements of the QMS in scope of the role.
Independently handles routine tasks with meticulous attention to detail.
Provides cross functional support.
Perform advanced data analysis on servicing, manufacturing, and quality data to identify trends, risks, and opportunities.
Ensure data accuracy, completeness, and consistency across systems and reports.
Drive and support data validation activities to ensure compliance with regulations.
Reports metrics monthly, quarterly, annually – creates dynamic Dashboard using tools such as PowerBI to extract data from multiple corporate systems to track and trend data for leadership and decision making.
Leads FAI/OBF/ELF meetings to align Service Quality and Operations Quality functions.
Performs any other assigned duties and responsibilities.