Service and Repair Quality Engineer at Johnson & Johnson

Danvers, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Healthcare, Medical DevicesIndustries

Requirements

5+ years of work experience in a highly regulated industry
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written)
Independent learner and critical thinker
Technical knowledge in applicable regulations, quality systems and operations for medical device service and repair and distribution activities including distribution, storage, transportation
Diverse business background with quality, regulatory and regulatory compliance competencies in commercial quality, supplier quality, storage, and distribution
Knowledge of Quality IT Systems

Responsibilities

Provides direct Quality support for S&R Operations owned escalation, non-conformance, CAPA and change control processes in North America and LATAM and indirectly to other global regions
Supports S&R operations during internal and external auditing and inspection
Supports implementation of processes, systems, resources, and SOPs, for the organization aligning with the J&J policies, J&J standards, applicable regulations and training requirements
Identifies risks, develops proposals and options, and builds consensus with key stakeholders on the determined solutions
Implements aligned processes and procedures at Abiomed to ensure compliant, efficient, and effective Commercial Quality operations in support of substantial growth forecast for the Abiomed business
Ensures appropriate self-training is planned and achieved to support compliant operations within Commercial Quality
Ensures technical and business self-development through robust development planning and execution
Performs other activities as required by management

Skills

Key technologies and capabilities for this role

Quality EngineeringCAPAChange ControlNon-conformanceSOPComplianceEscalation ManagementQuality Operations

Questions & Answers

Common questions about this position

Is this a remote position or does it require on-site work?

The role is located at Danvers, Massachusetts, United States of America, indicating it is an on-site position.

What are the essential duties of the Service and Repair Quality Engineer?

The role involves providing direct Quality support for S&R Operations including escalation, non-conformance, CAPA, and change control processes in North America and LATAM, supporting audits and inspections, implementing processes and SOPs aligned with J&J standards, and ensuring self-training for compliant operations.

What technical knowledge is required for this position?

Technical knowledge in applicable regulations and quality is required.

What is the employment type for this role?

This is a full-time position.

What makes a strong candidate for this Service and Repair Quality Engineer role?

A strong candidate will have technical knowledge in regulations and quality, experience supporting quality operations like CAPA, non-conformance, and audits, and the ability to implement J&J standards and SOPs while partnering with operations teams.

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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