Senior Supplier 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 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 Senior Supplier Quality Engineer 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 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 team-driven 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 Senior Supplier Quality Engineer serves as ABIOMED’s primary technical contact with suppliers, leads product development team’s supplier initiatives, second source critical suppliers, and establishes “Quality at the Source” programs with key partners. This role is a key technical resource for the company’s continued growth and is a great opportunity for someone to make a difference at one of the fastest-growing medical technology companies, focused on recovering hearts and saving lives.

The role is responsible for evaluating, monitoring, and improving the quality of products and services delivered by suppliers. This role involves working closely with suppliers, cross-functional teams, and internal quality departments to maintain high standards of product quality, safety, and regulatory compliance

Key Responsibilities:

Supplier Assessment: Assess and qualify new suppliers by evaluating their capabilities, quality control processes, and compliance with quality standards and regulatory requirements.

Quality Standards: Develop and maintain supplier quality standards, specifications, and inspection criteria. Ensure suppliers adhere to these standards.

Quality Audits: Participate in supplier audits activities to monitor their quality processes, identify non-conformances, and drive corrective and preventive actions.

Supplier Performance: Monitor and report on supplier performance metrics, such as defect rates, on-time delivery, and quality improvement initiatives.

Root Cause Analysis: Investigate and analyze quality issues and non-conformances, working with suppliers to identify root causes and implement corrective actions.

Quality Improvement: Collaborate with suppliers to implement quality improvement plans, including process changes, quality control methods, and continuous improvement initiatives.

Regulatory Compliance: Ensure suppliers meet all relevant regulatory and industry quality standards and requirements, particularly in regulated industries (e.g., medical devices, aerospace).

Risk Management: Identify and mitigate quality and supply chain risks associated with supplier activities.

Collaboration: Work closely with internal departments such as procurement, engineering, manufacturing, and quality assurance to ensure alignment and effective communication with suppliers.

Documentation: Maintain accurate and up-to-date records of supplier quality activities, audits, and quality agreements.

Training: Provide training and support to suppliers in quality management and process improvement.

Cost Management: