Quality Management Systems Specialist

Location: Bedford, Massachusetts Salary: US$60 - US$80 per hour + competitive
Sector: Medical Devices, Quality Assurance (QA) Type: Contract

I am partnering with a Medical Device organisation based North West of Boston to secure a QMS Master Control Specialist who will be managing the implementation and working to prepare for the system change. The company is currently paper-based and all documents need to be reformatted to Master Control format. The first part of the project will be to clean up current documentation and revise the formatting.

This is a 6 month contract which is very likely to extend and paying up to $65 an hour on an all-inclusive rate on a W2 basis and up to $80 an hour on C2C (not 1099 or single entities). The first part of the project will be to clean up current documentation and revise the formatting.

Key Responsibilities:

  • Manage the day to day operations of the project and continually communicate with the vendor (MasterControl) as it progresses, track progress, assess risk, ensure timeline of the project is on track and keep in communication with upper management. This person should have Project Management experience but must be a Master Control specialist more than a strict project Management.
  • Assist in the generation of the change control
  • Review Installation/Operation qualification (IOQ) validation packages of the system.
  • Perform or review the performance qualification (PQ) validation package of the system.

Knowledge and Experience:

  • Master Control, Electronic Document Management System (EDMS), QMS, Project Management skills
  • Bachelors Degree in the life sciences
  • Experience with managing previous Master Control implementation projects.
  • Minimum 1 year experience in Project Management
  • Minimum 4-5 years industry experience - Quality Management
  • Minimum 3 years experience within document control will be an advantage
  • Proficiency with Microsoft Office Suite and Visio; ability to maintain database systems preferred
  • Able to prioritize work flow daily and execute on multiple priorities in a fast paced environment
  • Excellent verbal and written communication skills

Sthree US is acting as an Employment Business in relation to this vacancy.