Senior Director, BWI Quality & Compliance

Irvine, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Candidates must possess a Bachelor's degree in Life Sciences or Engineering, with a Master's degree being preferred. A minimum of 12 years of experience in a regulated device environment is required, including at least 5 years in quality management or a related field. Experience with cardiac electrophysiology devices is preferred, along with excellent written and oral communication skills and a strong understanding of relevant product and quality system standards and regulations.

Responsibilities

The Senior Director, BWI Quality & Compliance will lead worldwide Quality functions, setting strategies and goals in alignment with regulatory requirements and company policies. This includes overseeing product quality aspects of development, lifecycle, supply chain, production, and support, as well as managing supplier qualification, product release, field actions, and complaint resolution. The role also involves leading quality services such as business process support, compliance, risk management, design assurance, audits, CAPA, records management, complaint handling, and quality data management. The individual will serve as the Management Representative and Person Responsible for Regulatory Compliance (PRRC) for BWI US sites, providing objective evaluations of quality performance and leading improvement initiatives. They will also partner with leaders to drive risk mitigation and continuous improvement, communicate quality vision, and recruit and retain quality professionals.

Skills

Quality Management System

Regulatory Requirements

Product Quality

Supplier Qualification

Product Release

Complaint Resolution

Quality Risk Management

Design Assurance

Internal Audits

Corrective and Preventive Action

Records Management

Document Control

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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