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Johnson & Johnson · 3 months ago

Sr. Supplier Quality Engineer- Shockwave Medical

Santa Clara, California, United States of America

Full-time

Onsite

Mid, Senior Level

$89K/yr - $143K/yr

5+ years exp

Johnson & Johnson is a leader in healthcare innovation, committed to developing personalized treatments. They are seeking a Sr. Supplier Quality Engineer to support manufacturing operations, manage suppliers, and collaborate with cross-functional teams to address quality issues and implement process improvements.

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

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

CGMPFDA 820 QSRISO 13485Supplier ManagementStatisticsSix SigmaLeanTechnical WritingProactiveEffective CommunicationSelf-motivatedIndependent Work

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

Company sponsored employee benefit programs

Consolidated retirement plan (pension)

Savings plan (401(k))

Long-term incentive program

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

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)