Johnson & Johnson MedTech · 1 week ago
Supplier Quality Engineer II- Shockwave Medical
Santa Clara, CA
Full-time
Onsite
Mid Level
$75K/yr - $121K/yr
3+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, and they are seeking a Supplier Quality Engineer II to join their team in Santa Clara, CA. The role involves supporting manufacturing operations, managing suppliers, and collaborating with cross-functional teams to address quality issues.
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
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)
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 the resolution of production line issues
Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team
Other duties as assigned
Qualification
Required
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
Ability to travel up to 10% of the time
Preferred
Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus
Benefits
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
This position is eligible to participate in the Company’s long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 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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