Quality Engineering Manager, New Product Development - 2406181700W

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

The Quality Engineering Manager supports the OTTAVA TM Surgical Robotics Platform, responsible for leading product quality and reliability while ensuring the implementation of ground-breaking technology for medical devices is safe, effective, and follows applicable regulations, standards, and industry practices. Working closely with multi-functional teams, this people leader will act as a domain authority for product quality throughout the development lifecycle. The Quality Engineering Manager will lead a team of Development Quality Engineers focusing on Instrument & Accessories. Additional responsibilities may include but are not limited to supporting other areas of the Quality Management System such as CAPA, Complaints, post market surveillance and both Internal & External Audits.

Key Responsibilities:

• The Quality Engineering Manager will lead a small team of direct reports potentially including engineers, technicians, and contractors.

• Drives the development of product risk management, design requirements, verification strategies, and validation strategies.

• Launch and stabilize new product launches through concept, design, development, and steady-state processes.

• Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards

• Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.

• Proactively engage partners to drive consensus and resolve issues in a timely fashion.

• Provide statistical support and expertise and analytical problem solving for product development and manufacturing.

• Review and approve design control, manufacturing, quality, engineering and validation / qualification documents for conformance business practices and departmental procedures.

• Provide support and expertise in developing and executing a reliability strategy during new product development.

• Conducts projects and assignments with technical responsibility.

Qualifications

Education:

• Bachelor’s Degree in Engineering from an accredited engineering school or relevant science field.

• Advanced Degree is preferred.

Experience and Skills:

Required:

• Minimum 8 years quality work experience, in a medical device area, or other highly regulated industry (automotive, aviation, aerospace, pharmaceutical, etc)

• Experience with medical electrical-mechanical systems

• New product development experience

• Knowledge of Quality Engineering/Scientific methods and techniques and applied statistics of increasing complexity

• Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation

• Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms

• Previous work experience engaging in a team-based environment

Preferred:

• Prior supervisory experience.

• Experience in medical device industry.

• ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean).

• Prior software quality engineering experience in a product development environment.

Other:

• Ability to travel up to 25% domestic and international

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

The base pay range for this position is $97,000 - $166,750

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-US-Ohio-Cincinnati

Organization Ethicon Endo Surgery Inc (6041)

Job Function Quality Engineering

Req ID: 2406181700W