Johnson & Johnson MedTech · 10 hours ago
Sr. Supplier Quality Engineer- Shockwave Medical
Santa Clara, CA
Full-time
Onsite
Mid, Senior Level
$89K/yr - $143K/yr
5+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, and they are seeking a Senior Supplier Quality Engineer to join their team in Santa Clara, CA. The role involves managing supplier quality issues, supporting manufacturing operations, and collaborating with cross-functional teams to ensure product quality and compliance.
Hospital & Health Care
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
Other duties as assigned
Qualification
Required
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
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
Able to lift objects weighing up to 25 lbs
Ability to travel up to 20% of the time
Preferred
Experience in the medical device industry is strongly preferred
Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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