Medical Device QS SME/PM

Minneapolis, MN

Job ID: 127004 Industry: Med

QS SME (Process/Procedural)

Environment:

Our client is a large medical device manufacturer. They manufacturing a number of class 2 and 3 medical devices. The client is currently in need of a senior level consultant to come in and work hands on with a medical device transformation project.  Standards are being updated for ISO 13485 and the EU and they will be replacing the current standards.  Our client needs to meet these new standards.

Principle Duties and Responsibilities:

The consultant will be responsible for helping the client stay up to date with current standards.  They will be helping keep the client complaint with new standards related to ISO 13485.

They have already done the gap assessment against the new regulations with their current regulations.  They will be partnering with SMEs on the process side to verify the gap assessments that were done.  They will be verifying them against the new regulations.  They will be getting up to date with ISO regulations.  Currently, they are in the stage of 2015 ISO.  They will be working from a hands on technical standpoint to update processes and procedures for any verified gaps.  They will be responsible for submitting redlines to process owners if necessary.  They will also need to help out with process changes.  They will need the internal audit in 2018 to come back with no gaps once the project is complete and have fully updated  ISO 13485 to the 2016 standard.  They must have experience with ISO 13485: 2016.  This consultant will be the point person at their new site, so they must have project management experience.  This site is also a paper based system, so they must be on site for the duration of the project.

Required:
  • Quality/Compliance
  • QS (Process/Procedures)
  • Medical Device
  • Project Management
  • ISO 13485

Job Type: Contract  

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