Manager, Quality Systems

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!

Description

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

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

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.