Talent.com
Supplier Quality Engineer II- Shockwave Medical
Supplier Quality Engineer II- Shockwave MedicalJohnson and Johnson • Santa Clara, CA, United States
Supplier Quality Engineer II- Shockwave Medical

Supplier Quality Engineer II- Shockwave Medical

Johnson and Johnson • Santa Clara, CA, United States
1 day ago
Job type
  • Full-time
Job description

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

Job Function :

Supply Chain Engineering

Job Sub Function : Quality Engineering

Job Category :

Scientific / Technology

All Job Posting Locations :

Santa Clara, California, United States of America

Job Description :

Johnson & Johnson is hiring for a Supplier Quality Engineer II – Shockwave Medica l 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

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 Supplier Quality Engineer II performs work with general supervision to provide and implement solutions to defined problems and assignments. The scope of responsibilities includes supporting manufacturing operations, managing suppliers, and working with cross-functional groups to address quality issues. The Supplier Quality Engineer II participates in decisions related to scope of work, risk management, process improvements, material disposition, and the implementation of revised product specifications.

Essential Job Functions

Supplier Management

  • Partner with Procurement, R&D, Operations, Quality, and Suppliers in the timely investigation, resolution, and prevention of supplier quality issues which could disrupt business operations
  • Monitor and analyze supplier performance metrics, identify improvement opportunities, and communicate supplier risks and / or opportunities to the next management level
  • Participate in the planning, scheduling, execution, and reporting of supplier audits
  • Participate in the initiation, issuance, review, and approval of Supplier Corrective Action Reports (SCARs)
  • Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions
  • Participate in component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups
  • Compile, analyze, and summarize supplier performance data for Supplier Scorecards

Manufacturing Support

  • Review, investigate, disposition, and drive to completion Non-conforming Reports (NCRs) and Corrective and Preventive Actions (CAPAs)
  • Initiate, review, and approve Document Change Orders (DCOs)
  • Provide technical support and guidance to the Quality Control group
  • Collaborate with Manufacturing Engineering on process improvement projects
  • Investigate customer complaints and document investigation findings
  • Participate in internal and third-party audits (FDA, Notified Body)
  • Participate in Material Review Board (MRB) meetings
  • Manufacturing Line Transfers

  • Assist in defining requirements and generating documentation for the transfer of manufacturing lines to Contract Manufacturers (CMs)
  • Assist in planning and providing on-site and off-site training to CMs on product inspection and testing
  • Monitor product quality and production rates at CMs and assist in the resolution of production line issues
  • Requirements J&J Credo : Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
  • Other duties as assigned
  • Qualifications

  • BS degree in a related engineering discipline and 3+ years of related experience, or
  • MS degree in a related engineering discipline
  • Experience in the medical device industry is strongly preferred
  • Knowledge of cGMP, FDA 820 QSR, ISO 13485, or other Quality Systems
  • Strong technical writing skills
  • Effective communication skills across all levels of the organization
  • Must be proactive, self-motivated, and able to work independently with minimal supervision
  • Ability to work independently in a fast-paced environment while managing multiple priorities
  • Knowledge of statistics (hypothesis testing, capability analysis, DOE, MSA), Six Sigma, Lean
  • Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus
  • Ability to travel up to 10% of the time
  • 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-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

    Required Skills : Preferred Skills :

    Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

    The anticipated base pay range for this position is :

    $73,000- $117,300

    Additional Description for Pay Transparency :

    Subject to the terms of their respective plans, employees and / or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs : medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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 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 Condolence Leave – 30 days for an immediate family member : 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below.

    Create a job alert for this search

    Supplier Quality Engineer • Santa Clara, CA, United States

    Related jobs
    Core Technologies Supplier Quality Engineer

    Core Technologies Supplier Quality Engineer

    Apple • Cupertino, CA, United States
    Full-time
    Imagine what you could do here.At Apple, new ideas have a way of becoming extraordinary products, services, and customer experiences very quickly. The people here at Apple don’t just build products ...Show more
    Last updated: 1 day ago • Promoted
    Verification and Validation Engineer / Senior V&V Engineer

    Verification and Validation Engineer / Senior V&V Engineer

    Bayside Solutions • San Mateo County, CA, US
    Full-time +1
    Verification and Validation Engineer / Senior V&V Engineer.Conduct design verification and validation testing for product development activities. Support all technical aspects of the product and i...Show more
    Last updated: 30+ days ago • Promoted
    Supplier Quality Engineer, Energy Storage

    Supplier Quality Engineer, Energy Storage

    Redwood Materials • San Francisco, CA, United States
    Full-time
    Redwood is localizing a global battery supply chain that seamlessly integrates recovery, reuse, and recycling.Supplier Quality Engineer, Energy Storage. As a Supplier Quality Engineer, you will ensu...Show more
    Last updated: 1 day ago • Promoted
    Senior Supplier Quality Engineer (Electronics)San Francisco

    Senior Supplier Quality Engineer (Electronics)San Francisco

    Astranis • San Francisco, CA, United States
    Permanent
    Senior Supplier Quality Engineer (Electronics).As a team, we've launched five satellites into orbit, signed ten commercial deals worth over $1 billion in revenue, raised over $750 million from top ...Show more
    Last updated: 1 day ago • Promoted
    Supplier Quality Engineer

    Supplier Quality Engineer

    Diverse Lynx • San Jose, CA, United States
    Full-time
    BS degree in electrical, mechanical, or industrial engineering or equivalent through experience.Quality Engineering experience in Compute system / Server / Consumer Electronics / Hardware manufacturing...Show more
    Last updated: 1 day ago • Promoted
    Senior Quality R&D Design Engineer, Med Device, Design Controls

    Senior Quality R&D Design Engineer, Med Device, Design Controls

    Eliassen Group • Redwood City, CA, US
    Temporary
    Senior Quality R&D Design Engineer - Design Controls, Risk Management.BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION. Our client is a privately held medical device company based in North...Show more
    Last updated: 1 day ago • Promoted
    Senior Supplier Quality Engineer in San Jose

    Senior Supplier Quality Engineer in San Jose

    Energy Jobline ZR • San Jose, CA, United States
    Full-time
    Energy Jobline is the largest and fastest growing global Energy Job Board and Energy Hub.We have an audience reach of over 7 million energy professionals, 400,000+ monthly advertised global energy ...Show more
    Last updated: 1 day ago • Promoted
    Supplier Quality Engineer

    Supplier Quality Engineer

    Wipro • Santa Clara, CA, United States
    Full-time
    Job Title : Supplier Quality Engineer.Wipro Limited (NYSE : WIT, BSE : 507685, NSE : WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address...Show more
    Last updated: 1 day ago • Promoted
    Executive Assistant, Quality and Operations

    Executive Assistant, Quality and Operations

    Calyxo, Inc. • Pleasanton, CA, United States
    Full-time
    The company was founded in 2016 to address the profound need for improved kidney stone treatment.Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resourc...Show more
    Last updated: 14 days ago • Promoted
    Plant Clearance & Production Quality / QC Consultant

    Plant Clearance & Production Quality / QC Consultant

    US Tech Solutions, Inc. • Milpitas, CA, US
    Temporary
    Duration : 12 months contract Job Description : This consultant will be responsible for conducting final audits, packaging inspections, and quality verification for all systems, upgrades, and miscell...Show more
    Last updated: 13 days ago • Promoted
    Supplier Quality Engineer - Senior

    Supplier Quality Engineer - Senior

    Experis • Holy, CA, US
    Full-time
    Our client, a leader in the manufacturing and supply chain industry, is seeking a dedicated and experienced Supplier Quality Engineer - Senior to join their dynamic team. As a key member of the Qual...Show more
    Last updated: 1 day ago • Promoted
    Senior Supplier Quality Engineer

    Senior Supplier Quality Engineer

    NVIDIA • Santa Clara, CA, United States
    Full-time
    NVIDIA has been transforming computer graphics, PC gaming, and accelerated computing for more than 25 years.It’s a unique legacy of innovation that’s fueled by great technology—and amazing people.N...Show more
    Last updated: 1 day ago • Promoted
    Senior Supplier Quality Engineer (Electronics) San Francisco

    Senior Supplier Quality Engineer (Electronics) San Francisco

    Astranis • San Francisco, CA, United States
    Permanent
    Senior Supplier Quality Engineer (Electronics).Astranis builds advanced satellites for high orbits, expanding humanitys reach into the solar system. Today, Astranis satellites provide dedicated, sec...Show more
    Last updated: 1 day ago • Promoted
    Supplier Quality Engineer - Senior

    Supplier Quality Engineer - Senior

    Manpower Group Inc. • Santa Clara, CA, United States
    Full-time
    Our client, a leader in the manufacturing and supply chain industry, is seeking a dedicated and experienced Supplier Quality Engineer - Senior to join their dynamic team. As a key member of the Qual...Show more
    Last updated: 1 day ago • Promoted
    Senior Supplier Quality Engineer

    Senior Supplier Quality Engineer

    PROCEPT BioRobotics • San Jose, CA, United States
    Full-time
    Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are c...Show more
    Last updated: 1 day ago • Promoted
    (Sr.) Production Quality Engineer

    (Sr.) Production Quality Engineer

    Supermicro • San Jose, CA, United States
    Full-time
    Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop / Big Data, Hyperscale, HPC and IoT / Embedded customers...Show more
    Last updated: 19 days ago • Promoted
    Medical Device Packaging Engineer I

    Medical Device Packaging Engineer I

    Penumbra, Inc. • Alameda, CA, US
    Full-time
    The mission of the Manufacturing Engineering group is to provide manufacturing technology and robust solutions that commercialize new products and that support continuous improvement in production....Show more
    Last updated: 1 day ago • Promoted
    Supplier Quality Engineer I

    Supplier Quality Engineer I

    Penumbra • Alameda, CA, United States
    Full-time
    As a Supplier Quality Engineer I at Penumbra, you will play a key role in ensuring our supply chain consistently delivers components and materials that meet the highest standards of quality and com...Show more
    Last updated: 1 day ago • Promoted