Senior Quality Engineer - MedTech Lifecycle & Compliance

Johnson & Johnson MedTech; Cincinnati (OH); On-site; USD 92,000 - 148,000; Full time

Benefits offered by this job

Vacation 120 hours/year

Sick time 40 hours/year

Holiday pay

Job summary

Johnson & Johnson MedTech in Cincinnati, OH is recruiting a Senior Quality Engineer to lead quality engineering across the product lifecycle, ensuring reliability and compliance with GMP, ISO, and medical device standards. The role involves collaboration with development, manufacturing and suppliers, and may require up to 10% travel.

The position emphasizes data-driven problem solving, risk management, and rigorous design control to meet customer and regulatory expectations.

Qualifications

• Bachelor’s degree in engineering or equivalent technical degree required.
• ASQ certification (CQE, CQM, CRE or CQA) is a plus.
• 4+ years of work experience in a regulated industry preferred.
• Experience with Risk Management (ISO 14971) and ISO 13485 is preferred.
• Auditing skills (ISO, QSR, MDSAP, GMP) are preferred.

Responsibilities

• Provide leadership in design and implementation of quality engineering to support product life cycle, with focus on reliability, risk management, statistics, verification/validation, and design control.
• Act as technical liaison between product development, manufacturing and suppliers; support audits and quality systems.
• Review and approve engineering documentation, release of new products and design changes.
• Apply quality engineering methods and comply with regulations and industry standards.
• Plan and conduct projects with technical responsibility and cross-functional input.
• Address and correct product and process complaints through data analysis and corrective actions.
• Communicate issues or opportunities to management; oversee audits of quality systems.
• Ensure measurement systems monitor effectiveness of quality and reliability systems.

Skills

Analytical Reasoning

Data Analytics

Root Cause Analysis

Statistics

Project Management

Regulatory Compliance

Team Collaboration

Communication

Education

Bachelor's degree in Engineering

Tools

SAP Product Lifecycle Management

Job description

Johnson & Johnson MedTech in Cincinnati, OH is recruiting a Senior Quality Engineer to lead quality engineering across the product lifecycle, ensuring reliability and compliance with GMP, ISO, and medical device standards. The role involves collaboration with development, manufacturing and suppliers, and may require up to 10% travel.

The position emphasizes data-driven problem solving, risk management, and rigorous design control to meet customer and regulatory expectations.