Sr Quality Systems Scientist I

Auris Health

Auris Health

Quality Assurance
Baltimore, MD, USA
Posted on Thursday, August 17, 2023


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 Sr Quality Systems Scientist I is responsible for maintaining the Environmental, Microbiology and Sterilizations systems and practices through the implementation of the appropriate Medical Device standards. The candidate will be a subject matter expert in these areas and coordinate all related activities across the organization.

Principle Duties and Responsibilities:

· Works with production to maintain control contamination practices.

· Facilitates the timely sampling of Bacterial Endotoxin and Bioburden samples.

· Works closely with engineering investigation teams to assure the timely closure of technical investigations.

· Works with R&D, manufacturing, and quality to bring new product and changes to existing products to completion as the sterilization SME.

· Coordinates, monthly, quarterly, and annual environmental monitoring testing.

· Works with sterilization vendors in order to resolve any non-conformances.

· Prepares metrics and trending reports for Sr. Management on a monthly basis.

· Provides direction regarding Corrective and Preventative Actions (CAPAs) that relate to the Product microbiology, sterilization, and environmental monitoring.

· Prepares risk assessments, protocols, and reports as necessary for EM and Sterilization projects.

· Assists management on departmental projects as necessary.


Job Qualifications:

· Bachelor’s degree or equivalent required.

· 5+ years of related work experience desired; Medical device experience preferred.

· Knowledge of lean, six sigma, kaizen and continuous improvement initiatives a plus.

· Excellent verbal and written communication skills.

· Strong organizational skills; must be detailed-oriented.

· Ability to execute tasks in a timely manner under general supervision.

· Strong knowledge of Microsoft Office Suite and Adobe Acrobat

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.