Staff NPD Quality Engineer

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Raynham, Massachusetts, United States of America

Job Description:

The Staff New Product Development (NPD) Quality Engineer provides Quality Engineering leadership on new product development projects in the areas of Design Controls and Design Transfer to Manufacturing including, but not limited to: Risk Management, Design Verification and Validation Strategies, and Design Transfer to Manufacturing. The Staff engineer operates at a high level of independence and has strong competency with problem solving and escalation pathways. This role is for our Joint Reconstruction organization supporting our Shoulder Reconstruction portfolio of products.

DUTIES & RESPONSIBILITIES

The Staff NPD quality engineer will be responsible for the following, but not limited to:

• Serve as lead quality engineer on cross functional new product development projects.
• Leads design transfer activities with internal and external (suppliers) stakeholders.
• Leverage technical competency in key core competency areas including but not limited to statistical techniques, GD&T, inspection methodologies, and process validations to support new product introduction.
• Leads root cause investigations using various problem solving techniques and tools.
• Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconformances, risk management, and audits.
• Provide leadership in the understanding of medical device regulations to other disciplines.
• Communicates effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Supply Chain, and Marketing.
• Mentors others in various technical capabilities.

Additional Duties:

• Responsible for communicating business-related issues or opportunities to next management level 

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. 

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable 

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures 

EXPERIENCE AND EDUCATION

• Bachelor’s degree in Engineering or related technical/scientific field AND 6 or more years related experience.
• Understanding of new product introduction processes, and expertise in process qualifications/validations.
• Strong knowledge of GD&T and inspection methodologies.
• Experience implementing appropriate risk mitigation with knowledge of product and process Risk Management (FDA & ISO standards).
• Advanced knowledge of Quality Engineering/Scientific Method techniques and principles.
• Demonstrates a strong understanding of all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconformances, risk management, and audit.
• Familiarity with manufacturing processes and controls.
• Experience with technical mentorship or managing co-ops/contractors preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

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