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Sr Quality Systems Engineer

Date:  Feb 14, 2021
Location: 

Danvers, MA, US, 01923

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,500 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
 

Job Responsibilities :

 

The Sr Quality Systems Engineer is responsible for supporting the Quality Assurance organization and ensuring compliance of the Quality Management System (QMS).

 

Principle Duties and Responsibilities:

 

  • Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system.
  • Oversee the company’s Internal Audit system, including tracking and follow-up on all audit findings.
  • Supervise the Documentation Control department.
  • Organization of quality data (Manufacturing, CAPA, etc) for trending and reporting.
  • Support and/or lead 3rd party audits, including follow-up on actions.
  • Partner with Process owners to generate and metrics, which reflect the health of different Quality System elements.
  • Support Internal Audit program, e.g., participate/lead Internal audits, follow up on the finding with auditee through effective closure, present the data for trending, etc.
  • Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).
  • Establish and support to Abiomed global training program.  
  • Support New Product Development projects, as needed.

Job Qualifications:

  • BS degree (or equivalent in experience) required.  MS preferred.
  • 5+ years Quality Assurance / Quality Systems experience in an FDA-regulated industry (medical device, pharmaceutical).
  • Experience in developing, customizing and/or implementing relational database applications, for quality data tracking and trending (SQL, Access, SAP, BusinessObjects, etc.) is desired.
  • 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 and familiarity with 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.
  • Able to prioritize tasks and manage multiple projects at once. 
  • SAP experience (Quality Module, DMS) a plus.
  • Must be proficient in Microsoft Office Suite.

 

 

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.


Nearest Major Market: Boston