Supplier Quality Engineer II- Shockwave Medical

Johnson & Johnson • Santa Clara, CA

57d • $73,000 - $117,300

About The Position

Johnson & Johnson is hiring for a Supplier Quality Engineer II – Shockwave Medical 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 https://www.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 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.

Requirements

• 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
• Ability to travel up to 10% of the time

Nice To Haves

• Knowledge of statistics (hypothesis testing, capability analysis, DOE, MSA), Six Sigma, Lean
• Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus

Responsibilities

• 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
• J&J Credo: Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
• Other duties as assigned

Benefits

• 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. https://www.careers.jnj.com/employee-benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees