Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

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 Change Requests 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

Qualifications

• Bachelor’s Degree or equivalent required
• 3 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 including Material Master configuration
• Good verbal and written communication skills
• Strong organizational skills; must be detailed-oriented and self-starter
• 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.