Abiomed is hiring for a Quality System Manager located in Danvers, MA.

Abiomed, recently acquired by Johnson & Johnson, is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 2,000 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

The Quality Systems Manager is responsible for the management of the Abiomed’s Quality System, collaborating cross functionally with various business units across multiple facilities to ensure that the Abiomed’s quality system requirements are effectively established and implemented to meet all applicable regulatory requirements.

Principle Duties and Responsibilities :

• Lead the establishment and maintenance of the Global quality system framework
• Oversee the company’s Internal Audit system, including tracking and follow-up on all audit findings
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Identify opportunities to proactively assure compliance to all applicable internal, domestic, and international regulations and quality standards
• Organize and drive effective cross-functional and cross-Business Unit (BU) collaboration on Quality improvement programs
• Lead continuous improvement of Quality Systems, such as CAPA, Deviation, Investigation, and Change Management, and direct the efforts to develop, implement and maintain compliant and effective Quality Systems
• A key responsibility of this role is managing people. which includes mentoring, developing and coaching staff on meeting/exceeding performance expectations
• Drive individuals and the team to continuously improve in key operational metrics and the achievement of the organizational goals
• Support New Product Development projects, as needed

Qualifications

Job Qualifications:

• BS degree is required, MS preferred
• 5 years of Quality Assurance / Quality Systems experience in an FDA-regulated industry (medical device, Biotech)
• Knowledge and application of QSR/GMP/GCP/ISO regulations as related medical devices manufacturing
• Working knowledge and practical application of 21 CFR Part 820, ISO 13485, EU MDR and ISO 14971
• Strong analytical and statistical skills
• Six sigma training/certification is a plus
• Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written)
• Ability to exercise judgment to determine methods, techniques, and evaluation criteria for obtaining results
• Executive Communication skills, Able to prioritize tasks and manage multiple projects at once
• SAP experience (Quality Module, DMS) a plus

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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 .]