NPD Quality Engineer

Position: Staff NPD Quality Engineer
This job is with Johnson & Johnson, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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 Med Tech, 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

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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:

Job Description:

Johnson & Johnson is recruiting for a Staff New Product Development Quality Engineer for our Joint Reconstruction Platform supporting Shoulder Reconstruction. This position is located in Raynham, MA.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company,  operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Job 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, and/or contributes to, 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.

Qualifications:

Bachelor's degree in Engineering or related technical/scientific field AND 6 or more years related experience.

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.

Understanding of new product introduction processes, and expertise in process qualifications/validations.

Experience implementing appropriate risk mitigation with knowledge of product and process Risk Management (FDA & ISO standards).

Experience working in a regulated environment. This includes knowledge of, and experience with, applicable standards, GxP requirements and regulations

Experience with technical mentorship or managing co-ops/contractors preferred.

Required Skills:

Leadership

Preferred

Skills:

Accelerating, Agility Jumps, Coaching, Communication, Compliance Management, Continuous Improvement,…