Sr. Quality Compliance Engineer- Shockwave Medical

Johnson & Johnson Co.; Santa Clara (CA); On-site; USD 91,000 - 147,000; Full time

Job summary

Johnson & Johnson is hiring a Senior Quality Compliance Engineer– Shockwave Medica to join our team in Santa Clara, CA. The role maintains quality compliance, assists in release of final product, and supports audit activities within our medical device division.

You will work on calibration, environmental monitoring, supplier controls, NCR/SCAR processes, and quality metrics, collaborating with R&D and manufacturing to ensure QMS and regulatory compliance.

Qualifications

• Bachelor’s degree in a related technical discipline with 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 equivalent Quality Systems.
• Ability to understand and follow QMS Procedures (SOPs and Test Methods).
• Proficiency in data compilation, analysis, presentation and document writing.
• Excellent written and verbal communication skills.
• Experience with computer-based applications (MS Word, MS Excel, QAD).
• Time management and multi-tasking in a fast-paced environment.

Responsibilities

• Review Production and Sterilization Records and release of Final Product to inventory.
• 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.
• Lead Equipment Calibration activities; validate new Calibration software.
• Coordinate with calibration vendors and ensure devices calibrated prior to due dates.
• Prepare and maintain Incoming Inspection Plans; train QA inspectors.
• Ensure Environmental Monitoring of cleanrooms is scheduled and performed.
• Coordinate Bioburden/Quarterly Dose Audit and sterilization parameter validation.
• Maintain NCR system; participate in NCR review meetings.
• Assist with audit preparation and manage audit findings.

Skills

Quality assurance

Data analysis

Documentation

Communication skills

Quality control

Education

Bachelor’s degree in a related technical discipline

Tools

MS Word

MS Excel

QAD

Job description

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 Medica 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 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 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. 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 cleanrooms 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 periodic Environmental Monitoring of the cleanrooms are scheduled and performed by an approved supplier
  • Review Environmental Monitoring test results 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
• Manage Competency program
  • Ensure Technician and Assembler competency program is implemented using a risk-based approach
• Assist with Supplier Controls
  • 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)
• Assist with maintaining the NCR System
  • 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

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 ([e-mail]) 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 - $147,200.00

Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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
• For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits