Director, Service & Repair Quality

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:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

People Leader

All Job Posting Locations:

Aachen, North Rhine-Westphalia, Germany, Danvers, Massachusetts, United States of America

Job Description:

Abiomed is recruiting for a Director, Service & Repair Quality to be located in Danvers, MA or Aachen, Germany.

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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-074680

Germany - Requisition Number: R-077189

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

The Director, Service & Repair Quality, has the responsibility for driving continuous quality improvements, maintaining Service & Repair compliance, providing global multi-site support, and presenting internal and external customer-facing needs to site leaders and business unit partners. This includes leadership in the delivery of critical Quality Control initiatives in the Service & Repair of Medical Devices. In addition, the Service & Repair Quality leader will identify and facilitate the implementation of key capabilities at the sites that will give the Quality organization a competitive advantage. In this role, they will coordinate regional efforts related to compliance, technology investments, regulations, and resource management/optimization.  This leader will be responsible for Service & Repair in the Danvers, Aachen, DE and Japan locations.

Key Responsibilities:

• Develops a world class service & repair quality organization through talent acquisition and internal talent movements to support Abiomed’s forecasted growth and ensure appropriate resources.
• Ensures the promotion of the awareness of the regulatory and customer requirements throughout the service and repair sites.
• Ensures that the Quality System is regularly audited/reviewed and that changes needed are implemented as required.
• Ensure that FDA and other regulatory knowledge and experience is applied to all Service & Repair systems including the FDA QSRs (GMP, CAPA, etc), ISO 13485, MDD, CMDCAS and other national and international quality and regulatory requirements and standard.
• Develop statistically sound sampling plans and perform data analysis to drive continuous improvement and resolve quality issues
• Develop, improve and maintain existing company quality objectives, and track and trend performance
• Designs, develop and maintains the Risk management programs for Service & Repair to ensure the company has risk-based quality processes in place in all areas
• Leads compliance support for Service & Repair during FDA and other regulatory compliance inspections
• Takes appropriate actions to build and maintain a working environment aligned with OUR CREDO
• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company gu