Quality Systems Engineer - Drive Compliance & Improvement

Johnson & Johnson Innovative Medicine; Danvers (MA); On-site; USD 79,000 - 128,000; Full time

Benefits offered by this job

Consolidated retirement plan (pension)

401(k) savings plan

Long-term incentive program

Vacation 120 hours/year

Job summary

Johnson & Johnson Innovative Medicine is seeking a Quality System Engineer to develop, implement, and maintain quality management systems ensuring compliance with industry standards and regulatory requirements. The role requires cross-functional collaboration across engineering, manufacturing, and regulatory teams.

You will drive continuous improvement initiatives, participate in audits, manage CAPAs, and provide staff training to reinforce a culture of quality across the organization.

Qualifications

• Bachelor’s degree in engineering or related field.
• Minimum three years' experience with quality systems in regulated industry.
• Knowledge of ISO, FDA, or other applicable standards.
• CQE or Six Sigma certification preferred.

Responsibilities

• Design and oversee quality control processes and documentation.
• Monitor system performance and track quality metrics.
• Conduct internal and external audits and support CAPA implementation.
• Provide training on quality system protocols.
• Collaborate with engineering, manufacturing, and regulatory teams.
• Track CAPAs and Non-Conformances with regulatory documentation.

Skills

Quality systems

Regulatory standards

Six Sigma CQE

Analytical skills

Communication

Education

Bachelor's degree in engineering

Quality Management

Job description

Johnson & Johnson Innovative Medicine is seeking a Quality System Engineer to develop, implement, and maintain quality management systems ensuring compliance with industry standards and regulatory requirements. The role requires cross-functional collaboration across engineering, manufacturing, and regulatory teams.

You will drive continuous improvement initiatives, participate in audits, manage CAPAs, and provide staff training to reinforce a culture of quality across the organization.