Johnson & Johnson is looking to solve complex healthcare problems by developing innovative medical devices, including Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, and is seeking a Sr. Supplier Quality Engineer to support manufacturing operations, manage suppliers, and address quality issues.
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
- 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
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
Other
- 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 20% of the time
- Able to lift objects weighing up to 25 lbs
- BS degree in a related engineering discipline
