BD · 22 hours ago
Sr. Quality Engineer, EMI, Quality Excellence
USA CA - San Diego TC Bldg C&D
Full-time
Onsite
Mid, Senior Level
$102K/yr - $168K/yr
4+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Sr. Quality Engineer, EMI, Quality Excellence, will ensure compliance with the BD MMS Quality Management System and manage metrics to support Operations and Service Quality, while driving continuous improvement across all QMS processes.
Health CareMedical DeviceTechnical Support
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
Qualification
Required
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
Preferred
Preferred certifications include Total Quality Management, Six Sigma, or similar
Benefits
A valuable, competitive package of compensation and benefits programs
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
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