BD (Becton, Dickinson and Company) Staff Quality System Specialist I in Franklin Lakes, New Jersey
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most sophisticated global health issues
About the role:
The Staff Quality System Specialist I is accountable for support of the continued development, improvement, and implementation of the Quality Systems. This position actively leads quality data analysis activities and participates in quality guidance, product resolution decisions, and project teams for process improvement and continuous improvement activities.
Key responsibilities will include:
Consistent application of Quality System standards
Actively leads the quality data analysis program, with excellent analytical and data management tools experience (e.g. MS Excel, SAP, databases, etc)
Develops solutions to routine assigned activities of moderate scope & complexity
Follows applicable Company / Unit procedures and may make updates to procedures and policies.
Works within and across functions for assigned Quality Systems.
Solid understanding of Quality Systems Regulatory requirements and application to Company / Unit requirements.
Subject matter expert / Super user at site/plant level for assigned quality system.
Education and experience required:
Typically requires a minimum of a Bachelor’s Degree in science, engineering, or other relevant subject area with 8+ years of relevant experience or a combination of equivalent education and relevant experience.
Moderate knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. 21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR).
Ability to use standard and approved Quality/Compliance methods
Knowledge in the application of Good Documentation Practices
Must have knowledge/specialization in one or more of the following areas:
Calibration, CAPA, Complaints, Computer System Validation, Continuous Improvement, Design Controls, Documentation Management, EU MDR/IVDR, Internal Audit, Label/IFU Controls, Management Review/Controls, Nonconforming Material/Processes, Post-Market Surveillance, Quality Data Analysis, Risk Management, Supplier Quality, Training
Click on apply if this sounds like you!
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
Becton, Dickinson and Company is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, or any other protected status.
Primary Work Location
USA NJ - Franklin Lakes
US BD 1st Shift 8am-5pm (United States of America)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.