Quality Systems Engineer — Drive Compliance & Improvement

6942-ABIOMED Inc. Legal Entity; Danvers (MA); On-site; USD 79,000 - 128,000; Full time

Benefits offered by this job

Pension plan

401(k) plan

Paid time off

Job summary

Johnson & Johnson in Danvers, MA is seeking a Quality System Engineer to develop, implement, and maintain quality management systems ensuring regulatory compliance. You will collaborate with cross-functional teams to identify improvement opportunities and promote ongoing quality initiatives.

The role requires a bachelor's degree in engineering or quality management and at least three years of experience with quality systems in regulated environments, including ISO and FDA standards.

Qualifications

• Bachelor's degree in engineering, quality management or a related field.
• At least three years of experience working with quality systems in a regulated industry.
• Comprehensive understanding of ISO, FDA or other applicable standards.

Responsibilities

• Design and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed.
• Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.
• Conduct internal and external audits and support corrective and preventive actions to address issues.
• Provide training and guidance to staff on quality system protocols, fostering a culture of quality.
• Work with engineering, manufacturing and regulatory teams to ensure seamless integration of quality standards.

Skills

Analytical Reasoning

Communication

Collaboration

Quality Auditing

Quality Control (QC)

Data Quality

Document Management

Quality Standards

Problem Solving

Training People

Education

Bachelor's degree in Engineering or Quality Management

Job description

Johnson & Johnson in Danvers, MA is seeking a Quality System Engineer to develop, implement, and maintain quality management systems ensuring regulatory compliance. You will collaborate with cross-functional teams to identify improvement opportunities and promote ongoing quality initiatives.

The role requires a bachelor's degree in engineering or quality management and at least three years of experience with quality systems in regulated environments, including ISO and FDA standards.