Quality Systems & Documentation Specialist II

BD; Franklin Lakes (NJ); On-site; USD 110,200 - 176,400; Full time

Benefits offered by this job

Annual Bonus

Medical coverage

BD 401(k) Plan

Paid time off

Job summary

BD is seeking a Quality System Specialist II to support the development, improvement, and implementation of the Quality Systems within Sustaining Engineering and New Product Development teams. You will contribute to quality guidance and product resolution decisions.

This role requires knowledge of FDA QSRs and ISO 13485, experience with documentation management, and familiarity with SAP or other QA tools. You will participate in audits, document control, and cross-functional projects.

Qualifications

• Bachelor’s degree in science, engineering, or related discipline and 2 years of relevant experience.
• High School Diploma and 10 years of experience are acceptable alternatives.
• Moderate knowledge of FDA medical device quality system regulations and ISO standards.

Responsibilities

• Supporting Documentation Management for Sustaining Eng and NPD projects using SAP.
• Performing tasks within planned schedules, supporting audits, and ensuring documentation compliance.
• Develops solutions to routine activities of limited scope and complexity.
• Follows Company procedures and updates to procedures as needed.
• Collaborates across functions for assigned quality system areas.

Skills

Quality systems knowledge

Documentation management

Audits

SAP

Education

Bachelor’s degree in science/engineering

High School Diploma with 10 years experience

Tools

SAP

Docusign

PEGA

Trackwise

Job description

BD is seeking a Quality System Specialist II to support the development, improvement, and implementation of the Quality Systems within Sustaining Engineering and New Product Development teams. You will contribute to quality guidance and product resolution decisions.

This role requires knowledge of FDA QSRs and ISO 13485, experience with documentation management, and familiarity with SAP or other QA tools. You will participate in audits, document control, and cross-functional projects.