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!

The Site Quality Leader is responsible for regulatory compliance of production within our Woburn facility. They ensure that all operational quality systems are in compliance with Abiomed internal policies and international medical regulations and quality data is available. They are responsible for supporting the manufacturing and supply chain.

Principle Duties and Responsibilities:

• Lead Manufacturing and Supplier Quality initiatives and support quality metrics, reporting, and help resolve quality issues
• Lead and support MRB activities ensuring appropriate resourcing to minimize value of MRB material and limit part shortages
• Conduct external audits of suppliers, execute on CAPA action and effectiveness activities, and support resolution of field complaints
• Lead/manage and assign tasks for quality goals and initiatives both long and short term with Woburn site team
• Develop, improve, and maintain existing company quality objectives, and track trend performance.
• Develop and improve existing quality data systems and provide regular quality data on a global basis
• Ensure the company has risk based quality processes in place in all areas
• Support all obsolescence programs with respect to suppliers
• Ensure quality relevant communication (Global, local, inside and outside the department)

Job Qualifications:

• BS Degree in a Scientific or Engineering discipline; MS preferred
• Minimum of 10 years of experience in a GMP-related field within a biotechnology or biologics manufacturing facility
• Minimum of 5 years leading Quality Programs and associated teams at a site, company or corporate level
• Knowledge of global quality systems and regulatory requirements (21 CFR Part 11/210/211/820, ISO 13485, PAL)
• Strong knowledge of GMP, SOPs and quality systems
• Works on multiple assignments in collaboration with various department system owners

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.