Sr Design Quality Engineer, Lifecycle Management at Johnson & Johnson

Irvine, 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

Provides quality technical and compliance expertise for modifying existing designs, supplier changes, internal manufacturing support, and lifecycle management activities
Uses engineering and supply chain knowledge to execute cross-functional projects supporting company strategies, goals, objectives, and product portfolio
Knowledge of scientific techniques and process excellence to modify/develop and validate safe, effective, and efficient processes
Provides technical support to ensure continuity of supply and compliance with applicable regulations
Leads quality activities such as risk assessments, device testing, audits, procedure development, documentation review, and changes to controlled documents
Provides design control, risk management, and compliance support for product design, manufacturing, corrective and preventive actions, product/process improvements, and complaint investigations
Works closely with R&D, Regulatory, Supply Chain, Clinical, and Marketing functions to create/maintain quality systems for product design and business needs
Ability to work on complex problems and provide highly innovative and comprehensive solutions
Applies scientific and engineering knowledge to development and improvement of medical device products, processes, manufacturing equipment, and validations
Works independently and in cross-functional teams (internal and external) to determine root cause, develop mitigations, and corrective/preventative actions for design, process, and manufacturing issues
Exercises judgment within generally defined practices and policies to select methods and techniques for solutions
Owns post-market surveillance activities
Evaluates manufacturing processes/products and collaborates with R&D, NPI, Sourcing, QA, Manufacturing, and Finance teams to lead projects/initiatives improving quality, productivity, and reducing costs

Responsibilities

Ensures Design control and Risk Management activities comply with quality system requirements
Executes Life Cycle Management projects in cross-functional settings as the design quality engineer core team member
Supports Design Changes of products in compliance with Cerenovus, Inc. Quality System and Johnson & Johnson policies/standards to enable compliant growth and robust high-quality product design/manufacture
Assures compliance to applicable international, federal, state, and local laws/regulations/requirements, and Corporate Johnson & Johnson procedures/guidelines under limited supervision

Skills

Design Quality Engineering

Lifecycle Management

Risk Assessments

Device Testing

Design Control

Process Validation

Supply Chain Engineering

Quality Compliance

Audits

Procedure Development

Documentation Review

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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