Senior Quality Compliance Engineer – MedTech IVL

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

Benefits offered by this job

401(k) plan

Pension plan

Long‑term incentive program

Vacation 120 hours/year

Sick time 40 hours/year

Job summary

Johnson & Johnson in Santa Clara, CA is hiring a Senior Quality Compliance Engineer – Shockwave Medical to join our team. You will help maintain quality compliance, assist in final product release, and oversee NCRs, CAPAs, and supplier controls in a fast-paced medical device environment.

The ideal candidate has 4–6 years in the medical device field, familiarity with cGMP, FDA 820 QSR, ISO 13485, and strong data analysis, documentation, and cross-functional collaboration skills.

Qualifications

• Bachelor’s degree in a related technical discipline preferred.
• Experience in the medical device industry strongly preferred.
• Understanding of QMS, FDA regulations, and GMP requirements.
• Proficiency in data compilation, analysis, and documentation.

Responsibilities

• Review production and sterilization records and release final product to inventory.
• Manage equipment calibrations and IQ/calibration activities.
• Coordinate with cross‑functional teams to address NCRs and CAPAs.
• Assist with audits and regulatory compliance activities.

Skills

QMS & quality systems

cGMP/FDA 820 QSR knowledge

ISO 13485 familiarity

Data analysis & presentation

Documentation & record keeping

MS Excel proficiency

Education

Bachelor’s degree in a related technical discipline

Tools

MS Word

MS Excel

QAD

Job description

Johnson & Johnson in Santa Clara, CA is hiring a Senior Quality Compliance Engineer – Shockwave Medical to join our team. You will help maintain quality compliance, assist in final product release, and oversee NCRs, CAPAs, and supplier controls in a fast-paced medical device environment.

The ideal candidate has 4–6 years in the medical device field, familiarity with cGMP, FDA 820 QSR, ISO 13485, and strong data analysis, documentation, and cross-functional collaboration skills.