Supplier Quality Engineer II

Johnson & Johnson Innovative Medicine • Santa Clara, CA

10d • $170,248 - $171,000 • Onsite

About The Position

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Requirements

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering or related field and 3 years of experience in job offered or in a Supplier Quality Engineer II-related occupation.
• Medical device industry experience.
• Experience with Quality Systems, including cGMP, FDA 820 QSR and ISO 13485.
• Experience with Statistical analysis using Minitab (hypothesis testing, capability analysis, DOE, and MSA).
• Experience with Six Sigma and Lean Manufacturing.
• Experience with Process Validation/Equipment Qualification (IQ/OQ/PQ).
• Experience with Risk Management Tools (dFMEA, pFMEA).
• Experience with Root Cause Analysis, Fishbone Diagram, Control Charts and Corrective Action Preventive Action (CAPA) for Non-Conforming Materials.
• Experience with Geometric Dimension & Tolerancing (GD&T) for Engineering Drawings using SolidWorks.
• Experience with Good Documentation Practices (GDP).
• Experience with Metrology and inspection tools (Calipers, MicroVu, Go/No-Go Gages).
• Lean Six Sigma Green Belt certificate required.
• SOLIDWORKS 2019 Essential Training certificate required.

Responsibilities

• Partner with Procurement, R&D, Operations, Quality, and Suppliers to ensure timely investigation, resolution, and prevention of supplier quality issues that could disrupt business operations.
• Monitor and analyze supplier performance metrics, identify improvement opportunities, and communicate supplier risks and/or opportunities to the next level of management.
• 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 guiding suppliers through true root cause analysis and implementing corrective and preventive actions.
• Participate in component qualification and 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.
• 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 findings.
• Participate in internal and third-party audits (e.g., FDA, Notified Body).
• Participate in Material Review Board (MRB) meetings.
• 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 resolving production line issues.

Benefits

• Medical
• Dental
• Vision
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year (or 48/56 hours in CO/WA)
• 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
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• Consolidated retirement plan (pension)
• Savings plan (401(k))
• Long-term incentive program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level