US - New Jersey - Franklin Lakes
January 2, 2025
Sr.
Quality Systems Specialist - Becton Dickinson Becton Dickinson Franklin Lakes, NJ
Summary The Sr.
Quality System Specialist is accountable for support of the continued development, improvement, and implementation of the Quality Systems.
This position actively participates in quality guidance, product resolution decisions, and project teams for process improvement and continuous improvement activities.
Job Responsibilities:
Consistent application of quality system standards to assigned quality system area.
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.
Working knowledge of quality systems regulatory requirements and application to Company/Unit requirements.
May perform other duties as required.
Education and Experience:
Requires a minimum of a bachelor's degree in science, engineering, or other relevant discipline and a minimum of 5 years of relevant experience or a combination of equivalent education and relevant experience.
Knowledge and Key Skills:
Working 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).
Working knowledge of applicable Corporate and/or Unit requirements.
Contributes to the completion of specific programs and projects.
Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
Able to revise policies and procedures.
Can independently determine and develop approach to solutions.
Ability to design and perform development while working independently within defined parameters under minimal supervision.
Can provide guidance and work direction to lower level project developers.
Can develop solutions to routine assigned activities of moderate scope & complexity.
Ability to prepare or revise policies and procedures.
Experience with BD software systems utilized in the Quality Systems is desirable.
Certified Quality Auditor or Transactional Six Sigma Green Belt desirable.
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.
Work Environment:
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry.
For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance.
COVID-19 Vaccination Requirement:
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19.
In some locations, testing for COVID-19 may be available and/or required.
Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us? 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.
To learn more about BD visit ***/careers
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.
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