Quality Specialist II at ABIOMED Inc. in Halethorpe, Maryland

Posted in Other 6 days ago.

Job Description:

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission ofRecovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700 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.

Patients First | Innovation | Winning Culture | Heart Recovery

The Quality Specialist is responsible for helping to maintain the quality system at the Baltimore location by taking direction from the quality manager to complete specific tasks in order to comply with applicable Medical Device standards.

Principle Duties and Responsibilities:

  • Process change control activities within the SAP system and coordinate the update of any associated master data. This includes changes to ECO Form, redlines, drawings, manufacturing inspection and assembly procedures, IFUs, labels, flowcharts, travelers, document Metadata etc., as well as implementing the changes with data entry of Bill of Materials, creation of BOMs, creation of Material Masters and Changes to Material Masters.

  • Assist Quality engineers in processing non-conformances, internal audits and CAPAs

  • Create training events and process training records

  • Assist management on departmental projects, as necessary with input

  • Other duties as specified.

Job Qualifications:

  • Bachelor Degree or equivalent required

  • 3 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.