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, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 2,000 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 RecoveryOverview :The Document Control Coordinator will maintain and improve the Abiomed Document control system and Training Management system.
Review and process Engineering Change Orders (ZEC) and maintain the control of quality records and quality system documents.Principle Duties and Responsibilities:In order to maintain a state of compliance with international quality standards, the Coordinator will work with other departments in order to maintain the global records systems and change order processesThe coordinator will identify process improvements in order to improve the efficiency and compliance of global documentation and record retention systemsCoordinate processes that maintain Master Data integrity of the SAP ERP systemCoordinate processes to maintain Quality System, manufacturing, and Product level software controlsProcess Engineering Change Orders using defined processes
– This includes changes to ECO Form, redlines, drawings, manufacturing inspection, assembly procedures, IFUs, labels, flowcharts, travelers, document Metadata etc., as well as implementing the Updates to Bill of Materials, Creation of BOMs, creation of Material Masters and Changes to Material MastersAssist users in assuring that all Change Order packets are accurate and completeMaintain Document Control’s ECO database and other shared drives that store records.
Support and coordinate training activities using LOOP system.
Communicates any issues back to Internal customers (ECO Originators)Assist in training other staff on proper procedures, document policies, ECO process, Portal (Intranet), LOOP and SAP DMS as needed.Assist management on departmental projects, as necessaryOther duties as specifiedJob Qualifications:Bachelor’s Degree or equivalent required5 years of experience maintaining electronic and physical record complianceStrong knowledge of Microsoft Office Suite and Adobe Acrobat is a MUSTChange control and/or configuration management.
Strong SAP experience preferredGood verbal and written communication skillsStrong organizational skills; must be detailed-orientedAbility to execute tasks in a timely manner under general supervisionAbiomed 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.Abiomed maintains a drug-free workplace.Nearest Major Market: Boston