Sr. Quality Compliance Engineer- Shockwave Medical

Johnson & Johnson•Santa Clara, CA

3d•Onsite

About The Position

Johnson & Johnson is hiring a Senior Quality Compliance Engineer to join their team in Santa Clara, CA. This role is crucial for maintaining quality compliance within the Shockwave Medical division, focusing on the development and commercialization of Intravascular Lithotripsy (IVL) for complex calcified cardiovascular disease. The position supports the release of final product, manages various quality systems, and ensures adherence to regulatory standards in a fast-paced, innovative environment.

Requirements

Bachelor’s degree in a related technical discipline preferred
4-6 years of related experience
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

Nice To Haves

Experience in the medical device industry is strongly preferred

Responsibilities

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.
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
Ensure periodic Environmental Monitoring of the cleanrooms are scheduled and performed by an approved supplier
Review Environmental Monitoring test data to ensure compliance, and work cross-functionally to address any non-conformances as needed
Responsible for coordinating Bioburden/Quarterly Dose Audit builds and ensuring sterility testing is performed per schedule.
Review test data to ensure validated sterilization parameters are valid
Perform ongoing review of Janitorial and Pest Control Records
Ensure Technician and Assembler competency program is implemented using a risk-based approach
Initiate and maintain supplier files on the Approved Supplier List
Gather information and update as needed to ensure supplier files are current and in compliance with Shockwave Medical Supplier procedures
Work cross-functionally to track and manage SCARs from initiation through closure
Compile quality metrics for trending purposes
Compile data and prepare presentations as needed for periodic reviews of the following Quality systems: NCRs, CAPAs, SCARs, Complaints, etc.
Identify additional data sets for trending to improve the Quality Management System(QMS)
Participate in NCR review meetings as needed
Work cross-functionally with other teams to track and manage NCR activities from initiation through closure
Identify and implement NCR system continuous improvement activities
Assist with audit preparation activities and management of related “Audit Findings”
Participate in quality system activities and serve as subject matter expert during internal and external audits
Coordinate audit related activities (prepare documents, track audit requests, take notes, schedule conference room, setup communication channel etc.)
Initiate, track and implement audit findings to address non-conformances
Manage backroom support activities during audits
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

Benefits

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program