Document Control Coordinator I

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, 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 Recovery

Overview:

The Document Control Coordinator II will maintain and improve the Abiomed Document control system. Review and process Engineering Change Orders (CRs) and maintain the control of quality records and quality system documents.

Principle Duties and Responsibilities:

• 
  To maintain a state of compliance with international quality standards, the coordinator will work with other departments to maintain the global records systems and change order processes.
• The coordinator will support in identifying process improvements to improve the efficiency and compliance of global documentation and record retention systems.
• Support processes to maintain Quality System, manufacturing, and Product level software controls.
• Process Engineering Change Orders using defined processes – This includes changes to Forms, 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 Masters.
• Assist users in assuring that all Change Order packets are accurate and complete.
• Maintain Document Control's ECO database and other shared drives that store records.
• Support training activities for the site using LOOP system wherever necessary.
• Communicates any issues back to Internal customers (CR Originators)
• Support development/ improvement activities associated with SAP system and PLM systems.
• Assist management on departmental projects, as necessary
• Other duties as specified

Job Qualifications:

• 
  Bachelor’s Degree or equivalent required
• 2 years of experience maintaining electronic and physical record compliance
• Strong knowledge of Microsoft Office Suite and Adobe Acrobat is a MUST
• Strong SAP experience preferred
• Good verbal and written communication skills
• Strong organizational skills; must be detailed-oriented
• Ability to execute tasks in a timely manner under general supervision

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. Abiomed maintains a drug-free workplace.