Job Description
Reporting to the Sr Manager of Global Quality Systems, The Sr. Quality Systems Engineer I is responsible for helping and supporting the Quality Systems organization from Abiomed GmBH location by ensuring compliance of the Global Quality Management System (QMS) with applicable Medical Device standards and regulations. 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.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).Support New Product Development projects, as needed.
Responsibilities + Skills
Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written), demonstrating strong analytical and statistical skillsAbility to exercise judgment to determine methods, techniques and evaluation criteria for obtaining results.
Education
Bachelors degree required. MS preferred.
Experience
