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Johnson & Johnson · 2 months ago

Supplier Quality Engineer II- Shockwave Medical

Santa Clara, California, United States of America

Full-time

Onsite

Mid Level

$73K/yr - $117K/yr

3+ years exp

Johnson & Johnson is a leader in healthcare innovation, committed to developing smarter and less invasive treatments. The Supplier Quality Engineer II will support manufacturing operations, manage suppliers, and work with cross-functional teams to address quality issues and implement solutions.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

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

Medical device experienceCGMP knowledgeFDA 820 QSR knowledgeISO 13485 knowledgeStatistics knowledgeSix SigmaLean methodologyTechnical writingProactive attitudeCustomer centricityData savvyDocument managementExecution focusIssue escalationProcess controlQuality controlQuality standardsQuality systems documentationSTEM applicationSupervisionSupply planningTechnologically savvyEffective communicationSelf-motivatedWork independently

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

Customer Centricity

Data Savvy

Document Management

Execution Focus

Good Automated Manufacturing Practice (GAMP)

Issue Escalation

Lean Supply Chain Management

Process Control

Process Improvements

Quality Control (QC)

Quality Services

Quality Standards

Quality Systems Documentation

Science, Technology, Engineering, and Math (STEM) Application

Supervision

Supply Planning

Technologically Savvy

Benefits

Medical

Dental

Vision

Life insurance

Short- and long-term disability

Business accident insurance

Group legal insurance

Company’s consolidated retirement plan (pension)

Savings plan (401(k))

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 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

Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member

Caregiver Leave – 10 days

Volunteer Leave – 4 days

Military Spouse Time-Off – 80 hours

Company

Johnson & Johnson

Glassdoor4.2

At Johnson & Johnson, we believe health is everything.

Founded in 1886

New Brunswick, NJ, US

10001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (48)

2024 (56)

2023 (58)

2022 (59)

2021 (44)

2020 (27)