PLM Analyst

ConforMIS, Inc. is a privately held medical device company based in Massachusetts. It was founded in 2004 to provide dramatic advancements in patient care by utilizing imaging technology to create personalized, patient-specific implants and instrumentation. Since its founding, it has raised in excess of $41 Million in financing and is currently a leader in the emerging category of patient-specific medical implants.Job Summary:

The primary responsibilities of this position are assisting with validation and implementation of Agile’s Product Lifecycle Management (PLM) Software System, Control of all Quality System Documents and Records for the QA and RA departments, revising existing paper-based Document Control procedures to fit the new electronic system, and training employees throughout the company on the new PLM System and procedures.  This position will also be responsible for the ongoing administration of the Agile system and other key elements of the document control process.  This position reports to the Director of Quality.

 

Essential Duties and Responsibilities:

- Transfer All Quality System Records & other documents to PLM System

 - Training Employees on Best Practices for Use of the PLM System 

-  Identifying Opportunities for Improvement in Business Systems to better take Advantage of the new PLM System; assist in workflow design for documentation and Quality System-related processes

 

- Training Department Managers to Generate Quality Trend Reports from the PLM and other enterprise systems

 

- Assist Director of Quality with Document Revision, Writing New Documents, and Preparing Presentations such as Management Review 

-Assist Director of Quality with administration of other elements of the company's Quality System

 

- Other duties upon request

 

 

Qualification Requirements/Knowledge/Skills/Abilities:

 

- Interpersonal skills are critical to this position, because the person will be required to work with several different departments and facilitate implementation of the Agile system in each of those departments.

 

- The successful candidate must be an expert user of of a PLM system; direct experience with Agile is a plus

 

- Previous experience implementing/validating Agile is a plus

 

- Medical Device experience is required: FDA QSR and ISO 13485:2003

 

- The ideal candidate will have experience managing Document Master Records (DMR), Design History Files (DHF), Technical Files (TF) and Design Dossier’s (DD) with an electronic PLM system.

 

-Proficiency in Microsoft Office and Adobe Acrobat is required, and the person should be comfortable training small groups of employees.



 

Education:

Bachelor’s Degree required.