Supplier Quality II

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

Job Function:

Quality

Job Sub Function:

Supplier Quality

Job Category:

Professional

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Supplier Quality Engineer II to be located in Danvers, MA.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

ABIOMED is redefining success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enables positive people to do profoundly important work.

The Supplier Quality Engineer II is responsible for cross-functional Quality Assurance, Quality Management/Compliance and activities associated with all Abiomed products and processes with a focus on supplier for the Danvers plant. This role involves hands-on project management, collaboration with multi-functional teams, and ensuring that supplier qualification processes align with quality standards and company objectives.

Primary Duties and Responsibilities:

• Develop and implement Supplier qualification plans, including risk assessments, quality audits, and performance evaluation
• Establish and communicate clear quality standards and criteria for new suppliers
• Collaborate with engineering and procurement teams to define specifications and expectations for supplier performance
• Develop project plans outlining milestones, timelines, and resource requirements for new supplier qualification projects
• Implement projects efficiently, ensuring alignment with overall business objectives and project deliverables
• Work closely with multi-functional teams, including procurement, Design engineering, manufacturing and sourcing to align project goals and expectations
• Communicate project progress, challenges, and results to management in a clear and timely manner
• Identify and assess risks associated with new supplier qualification projects
• Implement risk mitigation strategies to ensure the successful qualification of new suppliers
• Drive continuous improvement initiatives within the supplier qualification process, incorporating best practices and industry standards
• Analyze data and metrics to identify areas for improvement and implement corrective actions
• Generate reports summarizing project outcomes, supplier performance, and areas for improvement

Education

• Bachelor's or equivalent degree in Engineering or a related field is required. A Master's degree in Engineering is preferred.

Job Qualifications:

Required:

• 2 years of experience in Manufacturing, Design or Quality function within in the medical device field
• Strong analytical skills, including the ability to assess and mitigate risks
• Experience with formal problem-solving methodologies and deductive skills
• Good understanding of FDA QSRs, ISO13485, Ordinance 169, ISO14971

Preferred:

• Experience with handling non-conforming material and assemblies; including root cause investigations pertaining to such non-conformities
• Ability to adapt to changing priorities and thrive in a dynam