WayUp
Johnson & Johnson, Supplier Quality Engineer II- Shockwave Medical - Application
WayUp, Santa Clara, California, us, 95053
Johnson & Johnson, Supplier Quality Engineer II – Shockwave Medical
Join to apply for the Johnson & Johnson, Supplier Quality Engineer II – Shockwave Medical role. This position is with Johnson & Johnson and is being recruited in partnership with WayUp. 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/ Position: Supplier Quality Engineer II – Shockwave Medical Location: Santa Clara, CA 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 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 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) Assist in defining requirements and generating 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 Monitor product quality and production rates at CMs and assist in the resolution of production line issues Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with the team Qualifications
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 Knowledge of statistics (hypothesis testing, capability analysis, DOE, MSA), Six Sigma, Lean Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus Ability to travel up to 10% of the time Equal Opportunity
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 & Johnson is committed to providing an inclusive interview process. If you require accommodation, please contact the appropriate resource per the company policy. Salary and Benefits
Salary range and benefits vary by location and are provided in the posting per company policy. This position is eligible for company benefits as described in the employee benefits program. Notes
Referrals increase your chances of interviewing at WayUp. Job postings may include additional role-specific information and related opportunities. Santa Clara, CA — Typical posted ranges: $73,000.00 to $117,300.00 depending on experience. Other locations and ranges may apply.
#J-18808-Ljbffr
Join to apply for the Johnson & Johnson, Supplier Quality Engineer II – Shockwave Medical role. This position is with Johnson & Johnson and is being recruited in partnership with WayUp. 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/ Position: Supplier Quality Engineer II – Shockwave Medical Location: Santa Clara, CA 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 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 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) Assist in defining requirements and generating 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 Monitor product quality and production rates at CMs and assist in the resolution of production line issues Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with the team Qualifications
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 Knowledge of statistics (hypothesis testing, capability analysis, DOE, MSA), Six Sigma, Lean Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus Ability to travel up to 10% of the time Equal Opportunity
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 & Johnson is committed to providing an inclusive interview process. If you require accommodation, please contact the appropriate resource per the company policy. Salary and Benefits
Salary range and benefits vary by location and are provided in the posting per company policy. This position is eligible for company benefits as described in the employee benefits program. Notes
Referrals increase your chances of interviewing at WayUp. Job postings may include additional role-specific information and related opportunities. Santa Clara, CA — Typical posted ranges: $73,000.00 to $117,300.00 depending on experience. Other locations and ranges may apply.
#J-18808-Ljbffr