The Sr. Quality Systems Engineer is responsible for supporting the Quality Assurance organization and ensuring compliance of the Quality management System (QMS) through the implementation of the appropriate Medical Device standards. This person will be the subject matter expert in these areas and coordinate all activities related to them across the organization.
Primary Duties and Responsibilities:
Manage the Internal Audit system by scheduling, participating and leading internal audits. Support the organization in closing internal audit findings within a timely fashion.
Manage the Corrective and Preventative Action system by providing project management skills for the investigation and closure of CAPs in a timely fashion. Use technical/engineering knowledge to review and approve CAPA phases and assist CAPA teams in determining root cause.
Maintain the SOP Training database, ensuring employees are assigned appropriate training plans. Assure that training occurs in a timely fashion.
Maintain and Analyze quality systems metrics in order to determine the health of the quality system. Produce Quality system metrics in order to identify areas of improvement.
Use Six Sigma and Lean principles to improve quality system processes.
Manage the Process deviation system to ensure that deviation are appropriate and are closed in a timely fashion.
Support 3rd party audits (FDA, ISO, etc.).
Participate in the SPR (System Problem Report) and Failure Investigation processes, as needed.
Assist management on departmental projects, as necessary.
Other duties as specified.
Bachelor Degree in Mechanical Engineering or equivalent required
3-5 years of related work experience
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
Internal Number: 1430
Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: “Patients First.” With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,000 employees form one of the fastest growing medical technology companies in the world. Abiomed attracts and retains exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.