Sr. Quality Compliance Engineer- Shockwave Medical
Listed on 2026-08-07
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Quality Assurance - QA/QC
Quality Engineering, Quality Control - QC Analysts/Managers, Regulatory Compliance Specialist
Senior Quality Compliance Engineer– Shockwave Medical
Johnson & Johnson is hiring for a Senior Quality Compliance Engineer– Shockwave Medical to join our team in Santa Clara, CA.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. 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 Engineer maintains quality compliance, assists in release of final product, assists in maintaining the Receiving Inspection system, NCR system, Supplier controls, Competency Assessment Activity, Audit activities and compiling quality metrics for periodic reviews. This position may also provide quality engineering support for manufacturing but not limited to managing the calibration system and ensuring that the environmental monitoring of the clean rooms remain in compliance.
Essential Job Functions
- Review Production and Sterilization Records and release of Final Product to inventory
- Manage Equipment and Tool Calibrations
- Incoming Inspection
- Environmental Monitoring
- Manage Competency program
- Assist with Supplier Controls
- Compile quality metrics for trending purposes
- Assist with maintaining the NCR System
- Assist with audit preparation activities and management of related "Audit Findings"
- Review DV&V or other test data sheets to ensure accuracy and compliance to protocols and relevant procedures
- Provide guidance to other team members to ensure the QMS and Regulatory compliance requirements are met
- Work cross-functionally with other teams in tracking and ensuring Quality Objectives published during Management Reviews are met
- Support company goals and objectives, policies, and procedures, QSR, and FDA regulations
- Other duties as assigned
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
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-) or contact AskGS to be directed to your accommodation resource
Required Skills:
Preferred
Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards
The anticipated base pay range for this position is :
$91,000.00 - $
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are…
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