Medical Device QA Compliance Lead

Minneapolis, MN

Job ID: 130456 Industry: Med

Medical Device Compliance Lead

Environment:

Our client is a large medical device manufacturer.  They manufacture a number of class 1, 2 and 3 medical devices.  They are in need of a QA compliance SME to help with a new facility acquisition.

Job Duties/Responsibilities:

The consultant will be responsible for looking at our client’ s new facility. They will need to understand the facilities processes, procedures, and overall compliance with FDA rules and regulations.  There may be some re-engineering needed on the internal compliance system to make sure it is running properly.  They will need to be able to give transparent feedback to the client and prepare them for FDA visits.  They need to be strong in QA compliance and require minimal oversight.  They will be dealing with a post-acquisition assessment and be responsible for fixing/finding potential compliance issues.  They will also be working on product risk, so a risk management background will be important from a compliance aspect.  They will be given a list of deliverables and they must be able to prioritize them in order of importance and help with action items for each.  The majority of the work will be hands on internal auditing.  The previous employee was able to identify the most critical issues.  They must have the soft skills/project management skills to report back to upper management and present.  They must be comfortable doing hands on internal quality audits.  They need to be able to pick up a project, implement/maintain procedures and processes, and ensure that compliance is held throughout.  They also need to make sure they set up site readiness for audits.  It would also be a huge plus if they are familiar with MDSAP (Medical Device Single Audit Program).

Required:

Medical Device

QA Compliance

Pre-Audit Readiness

Internal QA Audits (Hands-On Perspective)

Excellent Communication/Soft Skills

Plus:

MDSAP (Medical Device Single Audit Program)

Job Type: Contract 

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