Senior Quality Compliance Engineer – MedTech Medical Devices

Shockwave Medical; Santa Clara (CA); On-site; USD 91,000 - 147,000; Full time

Benefits offered by this job

Vacation –120 hours/year

Sick time –40 hours/year

Holiday pay –13 days/year

Parental Leave – 480 hours/year

Job summary

Johnson & Johnson is hiring a Senior Quality Compliance Engineer– Shockwave Medica to join our team in Santa Clara, CA. The role focuses on maintaining quality compliance, assisting in final product release, and supporting environmental monitoring and NCR systems within a leading medical device environment.

The position involves cross-functional collaboration across manufacturing, R&D, and QA to ensure compliance with cGMP, FDA 820 QSR, and ISO 13485.

Qualifications

• Bachelor’s degree in a related technical discipline.
• 4–6 years of related experience in the medical device industry.
• Understanding of cGMP, FDA 820 QSR and ISO 13485.
• Ability to follow QMS procedures and document writing skills.
• Proficiency with MS Word, MS Excel, and QAD.

Responsibilities

• Review Production and Sterilization Records and release Final Product to inventory.
• Manage Calibration/Equipment control programs and environmental monitoring.
• Coordinate NCRs, CAPAs, SCARs, and audit activities.
• Assist with Supplier Controls and maintain Approved Supplier List.
• Compile quality metrics and support trending for QMS.

Skills

Quality Assurance

cGMP

FDA 820 QSR

Documentation

Education

Bachelor’s degree in related technical discipline

Tools

MS Word

MS Excel

QAD

Job description

Johnson & Johnson is hiring a Senior Quality Compliance Engineer– Shockwave Medica to join our team in Santa Clara, CA. The role focuses on maintaining quality compliance, assisting in final product release, and supporting environmental monitoring and NCR systems within a leading medical device environment.

The position involves cross-functional collaboration across manufacturing, R&D, and QA to ensure compliance with cGMP, FDA 820 QSR, and ISO 13485.