Sr. Quality Compliance Engineer- Shockwave Medical

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 Med Tech, 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

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Senior Quality Compliance Engineer
- Shockwave Medical to join our team 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 Med Tech, 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

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

* Review Production Records for accuracy and good documentation practice and compliance to respective Manufacturing Instructions

* Compile and monitor process control data

* Review sterilization records and lot release test data to ensure product can be released to inventory

* Ensure non-conformances/deviations and rework orders are resolved

* Manage Equipment and Tool Calibrations

* Lead the activities to implement and validate new Equipment Control software.

* Implement IQ and Calibration requirements in accordance with Manufacturer recommendation and internal requirements

* Harmonize equipment specifications, Installation Qualification and Calibration requirements

* Coordinate with calibration vendors and equipment manufacturers to ensure all tools and equipment are calibrated prior to their calibration due dates

* In the event of an out of tolerance condition, work cross-functionally to assess the risk and product impact, and how to resolve the situation

* Work with the Manufacturing Engineering group to ensure Preventive Maintenance is performed as scheduled.

* Incoming Inspection

* Work with R&D and Manufacturing Engineers to draft and maintain Incoming Inspection Plans

* Identify and implement Incoming Inspection measuring equipment. Train QA inspectors on such equipment

* Environmental Monitoring

* Ensure…