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Quality Systems Engineer - 2406192513W

Description

Johnson & Johnson is seeking a highly skilled Quality Systems Engineer to join our world-class team in Raynham, MA! In this role you will actively contribute to the flawless execution of our quality management system and lead continuous improvement initiatives to enhance our products and processes!

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/ .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Key Responsibilities:

• Support and drive continuous improvement of the quality system, Quality Systems metrics, and all Quality Systems programs across multiple locations.

• Actively engage in quality and compliance related activities, including quality system review, quality event and inspection management, to continuously improve our end-to-end quality management system.

• Support the design, development, and implementation of quality systems throughout the organization, ensuring compliance with applicable standards and regulations.

• Monitor and report on the effectiveness of quality systems, communicating results to management through the management review process.

• Mentor and enable Quality System functions organization wide, ensuring procedural requirements are met.

• Collaborate with cross-functional teams to establish quality systems procedures and support internal/external audits.

• Identify continuous improvement opportunities and support global initiatives to deliver best-in-class education and training for quality systems.

• Maintain current knowledge of regulatory changes and ensure compliance across the organization.

Qualifications

Education:

A minimum of a Bachelor's degree or equivalent in Engineering, Life Science, or a related field is required.

Experience and Skills:

Required:

• A minimum of two (2) years of experience in Quality Engineering, preferably in the Medical Device or Pharmaceutical Industry.

• Strong problem-solving and decision-making skills.

• Excellent written and verbal communication skills.

• Familiarity with 21 CFR 820 and/or MDD and/or ISO 13485 environment.

• Knowledge of basic quality tools and techniques.

• Solid understanding of compliance issues and risk management.

• Experience in supporting third-party inspections/audits.

• Excellent organizational and time management skills.

Other:

This position will be located in Raynham, MA and may require up to 10% domestic or international travel.

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.

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 (https://jnjc.taleo.net/enterprise/www.careers.jnj.com) .

Primary Location NA-US-Massachusetts-Raynham

Organization Medical Device Business Services, Inc (6029)

Travel Yes, 10 % of the Time

Job Function Quality Systems

Req ID: 2406192513W