Sr. Supplier Quality Engineer- Shockwave Medical

Johnson & Johnson Innovative Medicine • Santa Clara, CA

104d • $89,000 - $142,600

About The Position

Johnson & Johnson is hiring for a Sr. Supplier Quality Engineer – 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. 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.

Requirements

• 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.

Nice To Haves

• Experience in statistics (hypothesis testing, capability analysis, DOE, MSA, Gage R&R).
• Six Sigma and Lean Certifications (CQE, Lead Auditor, Six Sigma, Project Management).

Responsibilities

• 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.
• 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.
• 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.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Consolidated retirement plan (pension) and savings plan (401(k)).
• Eligible for an annual performance bonus.
• 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.
• Work, Personal and Family Time - up to 40 hours per calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees