Staff Supplier Quality Engineer

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 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 Staff Supplier Quality Engineer serves as ABIOMED’s primary technical contact with all US based suppliers, leads all 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 external 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.
• 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.
• Cross-functional 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.