Quality Engineering Team Lead at Johnson & Johnson

Raynham, Massachusetts, United States

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, OrthopaedicsIndustries

Requirements

Expertise in compliance to Global Regulations and standards (e.g., QSRs, ISO, EN, Medical Device Directive (MDD))
Experience conducting investigations, bounding, documentation, review, and approval of non-conformances, CAPAs, and customer complaints
Proficiency in material identification, segregation, and classification of defect types in manufacturing
Skills in analyzing/reviewing effectiveness of preventive and corrective actions and root cause investigations
Ability to serve as Subject Matter Expert (SME)
Knowledge in developing validation strategies and approving IQ, OQ, PQ, TMV, or Software Validation
Experience partnering with supply chain, finished goods, and material suppliers on process validation, control, risk management, and process failure investigations
Capability to collect data, perform analytical/statistical analysis, and interpret for process improvements

Responsibilities

Supervises Quality Engineers and conducts effective performance management
Manages operational aspects of the team (e.g., workflow, performance, compliance) and ensures achievement of team goals within standards
Champions compliance to applicable Global Regulations and standards, including support during internal and external audits
Conducts investigation, bounding, records documentation, review, and approval of non-conformances, CAPAs, and customer complaints; raises quality issues as appropriate
Accountable for material identification, material segregation, classification of defect types, and their day-to-day application in manufacturing
Analyzes/reviews effectiveness of preventive and corrective actions; reviews root cause investigations per established process
Represents as Subject Matter Expert (SME)
Supports or leads development of validation strategies
Approves IQ, OQ, PQ, TMV, or Software Validation
Partners with J&J Global Supply Chain, Finished Goods, and material suppliers to ensure process validation, control, risk management, and correction of process failures
Collects data and executes/conducts analytical/statistical analysis and interpretation for process improvements and day-to-day support
Documents, justifies, reviews, or analyzes proposed process changes to ensure they do not increase risk beyond current controls

Skills

Quality Engineering

Supply Chain Engineering

Team Leadership

Product Quality Assurance

Regulatory Compliance

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