Senior Quality Systems Architect

Regulatory Jobs; Franklin (NJ); On-site; USD 110,000 - 176,000; Full time

Benefits offered by this job

Annual Bonus

Discretionary Long-Term IncentiveBonus

Job summary

BD in Franklin Lakes, NJ is seeking a Sr. Quality System Specialist to support the ongoing development, improvement, and implementation of its Quality Systems.

The role participates in quality guidance, product resolution decisions, and project teams for process improvement and continuous improvement activities. Candidates should have a science/engineering background with 5 years of relevant experience, knowledge of FDA QSR and ISO 13485, and the ability to revise procedures.

Qualifications

• Bachelor’s degree in science, engineering, or other relevant discipline.
• 5 years of relevant experience.

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.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.

Skills

FDA quality system knowledge

Policy & procedure revision

Quality data analysis

Cross-functional collaboration

Education

Bachelor’s degree in science/engineering

Job description

BD in Franklin Lakes, NJ is seeking a Sr. Quality System Specialist to support the ongoing development, improvement, and implementation of its Quality Systems.

The role participates in quality guidance, product resolution decisions, and project teams for process improvement and continuous improvement activities. Candidates should have a science/engineering background with 5 years of relevant experience, knowledge of FDA QSR and ISO 13485, and the ability to revise procedures.