The Senior Quality Systems Engineer is responsible for supporting the Quality Assurance organization and ensuring compliance of the Quality Management System (QMS).
Principle Duties and Responsibilities:
Support the Internal Audit system by participating and leading internal audits.
Maintain the SOP Training database; ensuring employees are assigned appropriate training plans.
Coordinate quality data collection and statistical analyses
Manage the Corrective and Preventive Action (CAPA) system
Support 3rd party audits (FDA, ISO, etc.).
Participate in the SPR (System Problem Report) and Failure Investigation processes, as needed.
Skills/Requirements
Job Qualifications:
BS Degree in Engineering or Technical Field required
Minimum of 5 years experience in an FDA-regulated industry (medical device, pharmaceutical).
Medical device manufacturing experience preferred.
Experience auditing to 21 CFR Part 820 and ISO 13485.
Strong analytical, statistical and technical writing skills
Six sigma training/certification is a plus.
Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written)
Execute tasks in a timely manner under general supervision.
Able to prioritize tasks.
SAP experience (Quality Module, DMS, etc.) is a plus.
Must be proficient in Microsoft Office Suite.
Some travel may be required.
ABIOMED is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Veteran/Disabled.
