New Product Development (NPD) Quality Engineer II at Johnson & Johnson

Irvine, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, Medical DevicesIndustries

Requirements

A minimum of a bachelor’s degree required (preferably in Engineering or related technical field); or a minimum of 2 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
Ability to develop and implement Quality standards
Thorough knowledge of Quality systems and processes, including GMP and QSR requirements for medical devices
Knowledge of new product development design controls, and verification and validation (V&V) tools and methodologies
Demonstrated problem solving skills
Competent in using basic documentation applications such as MS Office (Word, Excel, Powerpoint, Outlook), Adobe PDF

Responsibilities

Provides product team support for multitude of new product development activities (e.g. engineering testing, design and process characterization, and other V&V activities)
Assists in conducting Quality Assurance documentation reviews and audits as needed
Support execution of risk management activities
Support development and execution of relevant process development and validation activities (e.g. IQ/OQ/TMV/APQ)
Utilizes multifaceted industry and process excellence standards in daily quality operations, including, but not limited to, good manufacturing practices (GMP) and Good Documentation Practices (GDP)
Assists in addressing product or process issues (internally or externally manufactured) or in investigating customer complaints as needed
Supports handling complex technical issues for manufacturing processes that are to be transferred to satellite facilities
Collaborate with cross-functional teams to achieve project team goals and objectives
Performs ongoing execution of and provides guidance to good manufacturing practices, compliance to internal and external policies and other applicable standards

Skills

Key technologies and capabilities for this role

Quality AssuranceNew Product DevelopmentQuality EngineeringSupply Chain EngineeringMedTechElectrophysiologyCardiac Arrhythmia

Questions & Answers

Common questions about this position

Is this a remote position or does it require working in an office?

The position is located in Irvine, California, indicating it is an on-site role.

What are the main responsibilities of this role?

The role involves providing quality assurance support for new product development projects, including engineering testing, design and process characterization, V&V activities, documentation reviews, risk management, process validation (IQ/OQ/TMV/APQ), and addressing product or process issues.

What skills or experience are required for this Quality Engineer position?

Key skills include knowledge of good manufacturing practices (GMP), Good Documentation Practices (GDP), risk management, process validation (IQ/OQ/TMV/APQ), and quality assurance for new product development activities.

What is the company culture like at Johnson & Johnson MedTech?

The company emphasizes innovation at the intersection of biology and technology to develop smarter, less invasive, personalized treatments, with a goal to empower electrophysiologists and improve lives for patients with cardiac arrhythmias.

What should I include in my application for this role?

Highlight experience in new product development quality assurance, GMP, GDP, risk management, process validation, and V&V activities for medical devices; note that an internal candidate is pre-identified but all applications are considered.

What is the salary or compensation for this position?

This information is not specified in the job description.

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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