Supplier Quality Engineer II- Shockwave Medical at Johnson & Johnson

Santa Clara, California, United States

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, Medical DevicesIndustries

Requirements

Performs work with general supervision to provide and implement solutions to defined problems and assignments
Supports manufacturing operations, manages suppliers, and works with cross-functional groups to address quality issues
Participates 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
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 disposition

Skills

Supplier Quality Engineering

Quality Assurance

Supply Chain

Medical Devices

FDA Regulations

ISO 13485

Risk Management

Auditing

CAPA

Statistical Analysis

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.

Land your dream remote job 3x faster with AI

Try Jobo Free