Process Quality Leader at Johnson & Johnson

San Lorenzo, Puerto Rico, Puerto Rico

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, Medical Devices, PharmaceuticalsIndustries

Requirements

Technical leadership in identifying causes of non-conformances and process failures
Knowledge of Ethicon’s QSR, GMP, and ISO requirements
Ability to work under limited supervision in accordance with federal, state, local laws/regulations, and Corporate Johnson & Johnson procedures/guidelines
Experience with data analysis, quality trends, analytical troubleshooting, FMEA, statistical concepts
Capability to provide technical supervision to multilevel, multifunctional teams, including Process Quality Technicians, College Recruits, Coops, or Supervisors
Compliance with environmental, safety, and occupational health policies (ISO14001 & OSHAS 18001)

Responsibilities

Reviews and analyzes quality trends with the manufacturing team and sets work priorities for process improvement
Provides mentorship to manufacturing supervisors for effective in-depth investigations
Leads and mentors multifunctional, multilevel technical teams to identify causes of non-conformance and implement corrective/preventive actions; evaluates their effectiveness
Leads investigations of negative trends and implements processes in alignment with Process Engineer, Quality Engineering, manufacturing, and facilities
Analyzes data and recommends actions for process, equipment, and system improvements based on trends
Writes procedures, protocols, and documentation for process and system improvements
Provides training and education to operations team on process evaluation tools (analytical troubleshooting, FMEA, statistical concepts, QSR/ISO requirements)
Leads CAPAs, recommends CAPAs based on negative trends
Handles, prepares data, and presents product escalation investigations (PRE’s), near misses, and QRB
Leads in-process investigations with multifunctional teams to determine root causes and recommend corrective/preventive actions
Handles preliminary investigations of product complaints, including analysis, trends, and recommendations or leads corrective/preventive actions
Provides technical supervision to multilevel, multifunctional teams on process improvement projects
Communicates business-related issues or opportunities to next management level
Ensures subordinates follow Company guidelines related to Health, Safety (if supervising staff)

Skills

Quality Engineering

Supply Chain Engineering

GMP

QSR

ISO

Root Cause Analysis

Process Improvement

CAPA

Trend Analysis

Technical Leadership

Manufacturing Processes

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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