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 Senior 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

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: Collaborate with suppliers to identify cost-effective quality improvement solutions and cost reduction initiatives.

Education:

• Bachelor's degree or equivalent experience in engineering or a related field.

Required:

• Minimum 4 years of professional engineering experience.
• Demonstrated ability in supplier quality engineering, quality control, or a related role.
• In-depth knowledge of quality management systems and standards (e.g., ISO 9001).
• Strong understanding of statistical analysis and quality improvement methodologies (e.g., Six Sigma).
• Experience with supplier audit processes and tools.
• Excellent problem-solving and root cause analysis skills.
• Strong communication skills.
• Strong interpersonal and teamwork skills.
• Ability to work in a multi-functional and diverse team environment.
• Strong organizational and time management skills.

• Master's of Science in Manufacturing Engineering, Mechanical Engineering, Material Science, or related science/engineering field
• Excellent technical communication and interpersonal skills
• Experience working in a multi-functional environment and partnering with design teams on new product development
• Expertise with statistical analysis techniques (process DOE, process validation/ stability/control/capability) and qualifying component manufacturing processes
• Experience in a regulated industry with the associated manufacturing environment and design control requirements
• Highly organized and creative, with strong analytical, problem-solving, and conflict analysis/resolution skills

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.