Sr. Supplier Quality Engineer - Shockwave Medical

Sr. Supplier Quality Engineer – Shockwave Medical

Johnson & Johnson is hiring for a Sr. Supplier Quality Engineer – Shockwave Medical to join our team located in Santa Clara, CA.

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 Sr. Supplier Quality Engineer performs work with general supervision to provide and implement solutions to broad problems and accomplishes complex assignments. The scope of responsibilities includes supporting manufacturing operations, managing suppliers, and working with cross-functional groups to address quality issues. The Sr. Supplier Quality Engineer 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
• Plan, schedule, execute, report, and follow-up on supplier audits
• Initiate, issue, review, and approve Supplier Corrective Action Reports (SCARs)
• Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions
• Own, manage, and drive to completion Supplier Change Assessments (SCAs)
• 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 periodic management reviews

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 Assurance group
• Support internal and third-party audits (FDA, Notified Body)
• Participate in Material Review Board (MRB) meetings

Manufacturing Line Transfers

• Partner with cross-functional teams to define requirements and generate documentation for the transfer of manufacturing lines to Contract Manufacturers (CMs)
• Plan and provide on-site and off-site training to CMs on product inspection and testing
• Act as the primary Quality point of contact with CMs, and provide remote and off-site support on matters related to Quality
• Other duties as assigned

Qualifications

• BS degree in a related engineering discipline and 5+ years of relevant experience, or
• MS degree in a related engineering discipline and 3+ years of relevant experience
• Experience in the medical device industry is strongly preferred
• Strong understanding 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
• Experience in statistics (hypothesis testing, capability analysis, DOE, MSA, Gage R&R), Six Sigma, Lean
• Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus
• Able to lift objects weighing up to 25 lbs
• Ability to travel up to 20% 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 or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $89,000 - $142,600. Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be 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. Employees may be 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. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.