Principal Supplier Integration & Quality Lead-DURATION BASED

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Supplier Quality

Job Category:

People Leader

All Job Posting Locations:

Danvers, Massachusetts, United States of America, Guaynabo, Puerto Rico, United States of America

Job Description:

Abiomed is recruiting for a Principal Supplier Integration & Quality Lead to be located in Guaynabo, PR. This is a duration-based role expected to only last for 12 months.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

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

The Principal Supplier Integration & Quality Lead serves as the primary Abiomed interface at the Critical Supplier (CS), providing single-point accountability for alignment across Quality, Engineering, Supply Chain, and Procurement functions.

This role ensures effective integration of Abiomed requirements into supplier operations, with direct oversight of activities impacting product quality, the Quality Management System, and regulatory compliance. It is accountable for maintaining alignment to Abiomed Quality System requirements and governing supplier adherence to change control, documentation, and release processes.

The position partners with CS leadership to drive quality performance, resolve complex issues, and support Joint Quality Reviews and Management Reviews. It leads cross-functional coordination to ensure timely execution of quality and operational priorities and provides clear escalation of risks impacting product quality, compliance, supply continuity, or regulatory status.

This is a senior individual contributor role with on-site influence, operating with a high degree of autonomy and authority to represent Abiomed interests at the supplier.

Key Responsibilities:

• Act as the primary on-site interface between Abiomed and the Critical Supplier
• Lead the Supplier Quality Improvement Plan (QIP) and drive performance improvements
• Provide oversight of Quality Engineering activities, e.g. supplier performance management, DHR approval
• Own Supplier Change Notices (SCNs), ensuring cross-functional alignment and timely implementation
• Support design and process changes, including SCAPA and field-related activities
• Analyze quality data, identify trends, and drive issue resolution
• Approve supplier NCs/CAPAs and initiate containment actions, including stop shipments as required
• Ensure compliance with Abiomed Quality System and Quality Agreement
• Support audits, regulatory interactions, and management reviews
• Partner with Engineering on validation, process capability, and technical transfers
• Collaborate with Global Procurement on supplier performance, strategy, and sourcing decisions
• Escalate risks impacting product quality, compliance, or supply continuity

Qualifications

Education:

• Bachelors or equivalent degree in Engineering, Quality, or related technical field is required

Experience and Skills:

Required:

• A minimum of 6-8 years of related experience
• Experience in a supplier-facing role within a regulated industry
• Demonstrated experience improving supplier performance and driving measurable quality outcomes
• Strong working knowledge of Quality Systems (QMS), CAPA, SCN, and regulatory requirements
• Proven ability to operate in a cross-functional, on-site or embedded supplier environment
• Strong analytical, communication, and escalation management skills

Preferred:

• Experience supporting medical device processes and regulatory expectations

Other:

• Intermediate Spanish proficiency preferred
• A minimum of 50% travel monthly to the Dominican Republic, requiring on-site presence at the supplier is required
• Occasional travel to Abiomed sites in Danvers and Aachen is expected. Specific terms will be aligned during the recruitment process.
• Relocation assistance will not be provided

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

 

 

Required Skills:

 

 

Preferred Skills:

Compliance Management, Continuous Improvement, Developing Others, Inclusive Leadership, Leadership, Operations Management, Performance Measurement, Product Testing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Relationship Building, Risk Management, Standard Operating Procedure (SOP), Team Management, Vendor Selection