Quality Systems Scientist II, Sterilization

Website Abiomed



The Quality Systems Scientist II, Sterilization 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:

Facilitates the timely completion of quarterly audits, monthly Bioburden and annual re-certification process for all sterilization modalities.
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.
Preparer 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.
Assists management on departmental projects as necessary.
Job Qualifications:

Bachelor Degree or equivalent required.
2+ 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.

To apply for this job email your details to talentacquisition@abiomed.com


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