Principal Quality Systems Specialist - Shockwave Medical

Johnson & Johnson MedTech; Santa Clara (CA); On-site; USD 105,000 - 170,000; Full time

Job summary

A leading company in the medical tech sector seeks a Principal Quality Systems Specialist in Santa Clara, CA. This role focuses on ensuring compliance with regulations, supporting quality system processes, and driving continuous improvement. Candidates should have extensive experience in medical devices and a strong grasp of industry standards.

Qualifications

• 10+ years of quality experience in Medical Devices.
• Strong knowledge of FDA, ISO13485, MDR, and global regulations.
• Experience in conducting internal audits and managing CAPAs.

Responsibilities

• Develop and maintain quality system procedures to ensure compliance.
• Participate in inspections and audits, assist in audit preparation and follow-up.
• Compile and analyze QMS metrics, prepare management review reports.

Skills

Communication

Organizational skills

Data analysis

Education

Bachelor's degree

Tools

MS Word

Excel

Oracle

ETQ

Job description

Principal Quality Systems Specialist - Shockwave Medical

Join to apply for the Principal Quality Systems Specialist - Shockwave Medical role at Johnson & Johnson MedTech.

Johnson & Johnson is seeking a Principal Quality Systems Specialist to join our team in Santa Clara, CA. We are committed to innovation in healthcare, developing smarter, less invasive treatments, and pioneering solutions like Intravascular Lithotripsy (IVL) for cardiovascular disease.

Position Overview

In compliance with FDA, European MDD/MDR & other international regulations, the Principal Quality Systems Specialist will support CAPA, data analysis, quality system processes, audits, and external standards management. This role requires knowledge of industry practices, regulations, and standards.

Essential Job Functions

• Develop and maintain quality system procedures to ensure compliance.
• Participate in inspections and audits, assist in audit preparation and follow-up.
• Identify and process preventive and corrective actions.
• Compile and analyze QMS metrics, prepare management review reports.
• Review and approve quality documents and reports.
• Lead improvement projects based on non-conformances and audit findings.
• Support new product and international requirements integration.
• Develop tools for standards and regulation tracking.
• Mentor and train team members.
• Support company policies, QSR, and FDA regulations.
• Drive continuous improvement activities within QMS.
• Implement JnJ standards, procedures, and work instructions.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree with 10+ years of quality experience in Medical Devices.
• Strong knowledge of FDA, ISO13485, MDR, and global regulations.
• Experience in conducting internal audits and managing CAPAs.
• Excellent communication, organizational, and data analysis skills.
• Proficiency with MS Word, Excel, Oracle, ETQ.
• Ability to work independently and as part of a team.

Johnson & Johnson is an Equal Opportunity Employer. We provide accommodations for applicants with disabilities upon request. The salary range for this position is $105,000 - $169,050, with performance-based bonuses and comprehensive benefits.