Senior Quality Compliance Engineer – IVL Medical Device

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

Job summary

Johnson & Johnson is hiring a Senior Quality Compliance Engineer (Shockwave Medical) to join our Santa Clara, CA team. You will ensure quality systems, support release of final products, manage audits, NCRs and supplier controls in a fast-paced medical device environment.

The role requires a technical degree, 4–6 years of related experience, knowledge of cGMP/FDA 820 QSR and ISO 13485, and strong data analysis, documentation, and communication skills.

Qualifications

• Bachelor’s degree in a related technical discipline preferred and 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 similar Quality Systems
• The ability to understand and follow QMS Procedures. (e.g., SOP and Test Methods)
• Proficiency in data compilation, analysis, presentation, and document writing skills
• Excellent written and verbal communication skills
• Experience with computer-based applications (MS Word, MS Excel, QAD)
• Time management skills and the ability to multi-task in a fast-paced environment
• Ability to work in a fast-paced environment while managing multiple priorities

Responsibilities

• Review DV&V test data sheets to ensure accuracy and compliance to protocols
• Provide guidance to other team members to ensure QMS requirements are met
• Review and manage NCRs, CAPAs, and audit findings
• Coordinate audit preparations and manage related activities
• Assist with maintaining the NCR System and supplier controls
• Compile quality metrics for trending and periodic reviews

Skills

Quality Assurance

Quality Systems

Data Analysis

Documentation

Communication

MS Excel

MS Word

QAD

Time management

Multi-tasking

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 Medical) to join our Santa Clara, CA team. You will ensure quality systems, support release of final products, manage audits, NCRs and supplier controls in a fast-paced medical device environment.

The role requires a technical degree, 4–6 years of related experience, knowledge of cGMP/FDA 820 QSR and ISO 13485, and strong data analysis, documentation, and communication skills.