Senior Quality Engineer - MedTech Lifecycle

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

Benefits offered by this job

Long-term incentive program

Pension plan

401(k)

Job summary

Johnson & Johnson MedTech in Cincinnati, OH is recruiting a Senior Quality Engineer to drive quality leadership across the product life cycle. You will focus on reliability, risk management, analysis, and design control, liaising with development, manufacturing, and suppliers.

The role requires strong problem-solving, familiarity with ISO 13485/GMP, and the ability to manage audits and quality systems while supporting process improvements. It offers competitive pay and benefits.

Qualifications

• Bachelor's degree in engineering or related technical field.
• Minimum 4 years in a regulated industry with quality focus.
• Familiarity with ISO 14971, ISO 13485, GMP and related standards.
• ASQ CQE/CQA certification is an asset.
• Experience with risk management and reliability analysis.

Responsibilities

• Lead quality engineering across product life cycle with risk management and analysis.
• Support quality systems audits and supplier quality efforts.
• Review and approve engineering docs and design changes for quality.
• Ensure compliance with regulatory standards and internal policies.
• Coordinate cross functional teams on quality improvements.

Skills

Analytical reasoning

Data savvy

Biostatistics

Project management

Team collaboration

Research & development

SAP Product Lifecycle Management

Education

Bachelor's degree in engineering

ASQ CQE/CQA asset

Tools

ISO 14971 knowledge

ISO 13485 familiarity

Gage R&R & MSA

Job description

Johnson & Johnson MedTech in Cincinnati, OH is recruiting a Senior Quality Engineer to drive quality leadership across the product life cycle. You will focus on reliability, risk management, analysis, and design control, liaising with development, manufacturing, and suppliers.

The role requires strong problem-solving, familiarity with ISO 13485/GMP, and the ability to manage audits and quality systems while supporting process improvements. It offers competitive pay and benefits.