Senior Quality Compliance Engineer – MedTech

Johnson & Johnson Co.; Santa Clara (CA); On-site; USD 91,000 - 147,000; Full time

Job summary

Johnson & Johnson is hiring a Senior Quality Compliance Engineer– Shockwave Medica to join our team in Santa Clara, CA. The role maintains quality compliance, assists in release of final product, and supports audit activities within our medical device division.

You will work on calibration, environmental monitoring, supplier controls, NCR/SCAR processes, and quality metrics, collaborating with R&D and manufacturing to ensure QMS and regulatory compliance.

Qualifications

• Bachelor’s degree in a related technical discipline with 4-6 years of related experience.
• Experience in the medical device industry is strongly preferred.
• Understanding of cGMP, FDA 820 QSR and ISO 13485 or equivalent Quality Systems.
• Ability to understand and follow QMS Procedures (SOPs and Test Methods).
• Proficiency in data compilation, analysis, presentation and document writing.
• Excellent written and verbal communication skills.
• Experience with computer-based applications (MS Word, MS Excel, QAD).
• Time management and multi-tasking in a fast-paced environment.

Responsibilities

• Review Production and Sterilization Records and release of Final Product to inventory.
• Compile and monitor process control data.
• Review sterilization records and lot release test data to ensure product can be released to inventory.
• Ensure non-conformances/deviations and rework orders are resolved.
• Lead Equipment Calibration activities; validate new Calibration software.
• Coordinate with calibration vendors and ensure devices calibrated prior to due dates.
• Prepare and maintain Incoming Inspection Plans; train QA inspectors.
• Ensure Environmental Monitoring of cleanrooms is scheduled and performed.
• Coordinate Bioburden/Quarterly Dose Audit and sterilization parameter validation.
• Maintain NCR system; participate in NCR review meetings.
• Assist with audit preparation and manage audit findings.

Skills

Quality assurance

Data analysis

Documentation

Communication skills

Quality control

Education

Bachelor’s degree in a 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 maintains quality compliance, assists in release of final product, and supports audit activities within our medical device division.

You will work on calibration, environmental monitoring, supplier controls, NCR/SCAR processes, and quality metrics, collaborating with R&D and manufacturing to ensure QMS and regulatory compliance.