Sr. Quality Compliance Specialist - Shockwave Medical

Jnjmedtech; Santa Clara (CA); On-site; USD 89,000 - 143,000; Full time

Job summary

A leading company in the medical device sector seeks a Sr. Quality Compliance Specialist to enhance quality processes. The role focuses on maintaining compliance with industry standards, auditing, and ensuring product quality in a dynamic environment in Santa Clara, California.

Benefits

Performance-based bonuses

Comprehensive benefits

Retirement and savings plans

Paid time off

Incentive programs

Qualifications

• 5+ years of related experience in medical device quality systems.
• Knowledge of cGMP, FDA 820 QSR, ISO 13485.
• Proficiency in data analysis and documentation.

Responsibilities

• Review production and sterilization records and release final products.
• Coordinate with functions to gather information and prepare reports.
• Manage audit-related activities and ensure compliance.

Skills

Data analysis

Communication

Organizational skills

Multitasking

Time management

Education

Bachelor’s degree

Tools

MS Word

MS Excel

QAD

Job description

Sr. Quality Compliance Specialist - Shockwave Medical

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description

Johnson & Johnson is hiring for a Sr. Quality Compliance Specialist – Shockwave Medical to join our team located in Santa Clara, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Senior Quality Compliance Specialist will perform work under general supervision, assisting in maintaining quality compliance, supporting audit activities, reviewing lot history records, processing non-conforming reports, maintaining data logs, supporting External Standards management, and compiling quality metrics. This role requires knowledge of industry practices, techniques, and standards.

Essential Job Functions

• Review production and sterilization records and release final products.
• Ensure records accuracy and compliance with procedures.
• Coordinate with various functions to gather information.
• Compile and monitor process control data.
• Prepare reports for trending and analysis.
• Assist with audit preparations and conduct internal and external audits.
• Manage audit-related activities and communicate with Subject Matter Experts.
• Assist with External records management and standards compliance.
• Gather information to ensure compliance with procedures.
• Support quality metrics analysis and reporting.
• Maintain NCR System and manage NCR activities from initiation to closure.
• Identify and implement NCR system improvements.
• Perform data entry and generate reports.
• Support company policies, QSR, and FDA regulations.
• Other duties as assigned.

Qualifications

• Bachelor’s degree and 5+ years of related experience in medical device quality systems.
• Knowledge of cGMP, FDA 820 QSR, ISO 13485, or similar standards.
• Proficiency in data analysis, presentation, and documentation.
• Excellent communication and organizational skills.
• Experience with MS Word, MS Excel, QAD.
• Strong multitasking and time management skills.

Pay Transparency

• Salary range: $89,000 - $142,600.
• Performance-based bonuses and comprehensive benefits.
• Eligible for retirement and savings plans, paid time off, and incentive programs.

Johnson & Johnson is an Equal Opportunity Employer. We value diversity and inclusion and actively seek qualified candidates from all backgrounds. For accommodations during the interview process, contact [e-mail].