Senior Quality & Compliance Engineer, MedTech

6947-SHOCKWAVE MEDICAL INC. Legal Entity; Santa Clara (CA); On-site; USD 91,000 - 147,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Quality Compliance Engineer– Shockwave Medical to join our Santa Clara, CA team. The role focuses on maintaining quality compliance, product release support, and overseeing NCR/SCAR processes while ensuring environmental monitoring and calibration programs meet regulatory standards.

The candidate will coordinate audits, collaborate with R&D and Manufacturing, and drive continuous improvement of the QMS in a fast-paced medical device environment.

Qualifications

• Bachelor’s degree in a related technical discipline; 4–6 years of related experience.
• Experience in the medical device industry is strongly preferred.
• Understanding of cGMP, FDA 820 QSR and ISO 13485.
• Ability to understand and follow QMS procedures.
• Proficient in data compilation, analysis, and documentation.
• Excellent written and verbal communication skills.

Responsibilities

• Review production and sterilization records and release final product.
• Coordinate calibration and environmental monitoring activities.
• Lead audits and manage NCR/CAPA/SCAR processes.
• Prepare quality metrics and reports for management reviews.
• Collaborate cross-functionally to ensure QMS compliance.

Skills

Quality Compliance

Data Analysis

Problem Solving

Quality Management Systems

Regulatory Knowledge

Education

Bachelor’s degree in a related technical discipline

Tools

MS Word

MS Excel

QAD

Job description

Johnson & Johnson is seeking a Senior Quality Compliance Engineer– Shockwave Medical to join our Santa Clara, CA team. The role focuses on maintaining quality compliance, product release support, and overseeing NCR/SCAR processes while ensuring environmental monitoring and calibration programs meet regulatory standards.

The candidate will coordinate audits, collaborate with R&D and Manufacturing, and drive continuous improvement of the QMS in a fast-paced medical device environment.