Sr. Supplier Quality Engineer- Shockwave Medical at Johnson & Johnson

Santa Clara, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Healthcare, Medical DevicesIndustries

Requirements

Ability to perform work with general supervision to provide and implement solutions to broad problems and accomplish complex assignments
Experience supporting manufacturing operations, managing suppliers, and working with cross-functional groups to address quality issues
Participation in decisions related to scope of work, risk management, process improvements, material disposition, and implementation of revised product specifications

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 on manufacturing line transfers

Skills

Key technologies and capabilities for this role

Supplier Quality EngineeringQuality EngineeringSupply Chain EngineeringMedical DevicesRegulatory Compliance

Questions & Answers

Common questions about this position

Is this a remote position or does it require on-site work?

The position is located in Santa Clara, California, indicating it requires on-site work at that location.

What is the salary range for this Sr. Supplier Quality Engineer role?

This information is not specified in the job description.

What are the key responsibilities of this role?

The role involves supplier management, partnering with cross-functional teams to resolve quality issues, monitoring supplier performance metrics, and participating in risk management and process improvements.

What is the company culture like at Johnson & Johnson?

Johnson & Johnson emphasizes healthcare innovation to prevent, treat, and cure complex diseases with smarter, less invasive, and personalized solutions, fostering a pioneering team environment focused on impactful breakthroughs.

What makes a strong candidate for this position?

A strong candidate can perform work with general supervision, solve broad problems, accomplish complex assignments, and has experience in supplier management, cross-functional collaboration, and quality issue resolution.

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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