Senior Quality Engineer - MedTech Lifecycle Leader

6041-Ethicon Endo Surgery Inc Legal Entity; Cincinnati (OH); On-site; USD 92,000 - 148,000; Full time

Job summary

Johnson & Johnson MedTech in Cincinnati, OH, is hiring a Senior Quality Engineer to lead quality assurance activities across the product life cycle. You will ensure compliance with GMP, ISO standards, and risk management while collaborating with development and manufacturing teams.

You will apply statistical methods, support supplier quality, and drive continuous improvement through data analysis and CAPA initiatives. The role emphasizes cross-functional leadership in a regulated environment.

Qualifications

• Bachelor's degree in engineering required.
• Minimum 4 years' work experience in a regulated environment.
• ASQ certification (CQE/CQA) asset not required.
• Experience with ISO 14971/ISO 13485 and GMP advantageous.
• Auditing (ISO, QSR, MDSAP, GMP) preferred.
• Strong analytical/problem-solving and data analysis skills.

Responsibilities

• Provide leadership in quality engineering across product life cycle.
• Support design verification and test method development.
• Oversee audits of quality system categories for compliance.
• Lead root cause investigations and corrective actions.
• Communicate issues and opportunities to management.
• Ensure compliant documentation and change control.

Skills

Analytical problem-solving

Root cause analysis

Statistical methods

Project management

Team collaboration

Regulatory knowledge

Quality systems

Risk analysis

Education

Bachelor's degree in engineering

Mechanical/Electrical/Biomedical preferred

Tools

SAP Product Lifecycle Management

Quality management software

Gage R&R

Job description

Johnson & Johnson MedTech in Cincinnati, OH, is hiring a Senior Quality Engineer to lead quality assurance activities across the product life cycle. You will ensure compliance with GMP, ISO standards, and risk management while collaborating with development and manufacturing teams.

You will apply statistical methods, support supplier quality, and drive continuous improvement through data analysis and CAPA initiatives. The role emphasizes cross-functional leadership in a regulated environment.