Quality Systems Specialist II: Document Control

bdx; Franklin Lakes (NJ); On-site; USD 110,000 - 176,000; Full time

Benefits offered by this job

Annual Bonus

Potential Discretionary LTI Bonus

Job summary

BD in the United States (Franklin Lakes, NJ) seeks a Quality System Specialist II to support development and improvement of Quality Systems. You will participate in guidance, product decisions, and continuous improvement within cross-functional teams.

Responsibilities include managing documents, engineering change orders, and design history files with SAP, ensuring compliance, and contributing to audits. Requirements include a related degree or equivalent experience, and knowledge of quality

Qualifications

• Experience with FDA medical device quality system regulations and ISO standards.
• Ability to apply quality system standards to the assigned area.
• Knowledge of Good Documentation Practices and audits.
• Experience with documentation management, EDRs, and design history files.
• Familiarity with SAP, Docusign, PEGA, Trackwise is desirable.

Responsibilities

• Support Documentation Management for Sustaining Eng and NPD projects using SAP.
• Assist in audits, retrieval of documents, and ensure compliance across programs.
• Develop solutions to routine activities within scope and timelines.
• Follow procedures and update policies as needed.
• Collaborate across functions on quality system activities.

Skills

FDA quality systems

Documentation

Team collaboration

Audits

Quality assurance

Education

High School Diploma + 10 years experience

Bachelor's in science/engineering

Tools

SAP

Docusign

PEGA

Trackwise

Job description

BD in the United States (Franklin Lakes, NJ) seeks a Quality System Specialist II to support development and improvement of Quality Systems. You will participate in guidance, product decisions, and continuous improvement within cross-functional teams.

Responsibilities include managing documents, engineering change orders, and design history files with SAP, ensuring compliance, and contributing to audits. Requirements include a related degree or equivalent experience, and knowledge of quality