Supplier Quality Engineer II- 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 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.