Junior Mdsap Project Manager (FDA)

Junior MDSAP Project Manager (FDA)

Start date: ASAP

Actual End date: 14/07/2018

Location: Braine l'Alleud

Killing criteria:

- 2 years' experience in project coordination minimum
- Excellent communication skills
- English Fluent
- Availability to be on site 5 days a week in Braine l'Alleud

Summary:

Support in Medical Device Single Audit Program implementation (global project).
Project management for the program (weekly updates, meetings/follow with the sites, preparation meetings, support during audits)

Tasks:

- Management of the program implementation and reporting to governance board on a weekly basis
- Planning and weekly follow up with the sites on program implementation
- Support in MDSAP training
- Support in preparation and execution of MDSAP audits
- Collecting gaps and escalate to Global QMS owners
- Collect and maintain MDSAP audit observations file for all MDSAP locations. Track corrective actions/gaps resolution, present during MDSAP meetings.
- Develop and maintain MDSAP SharePoint site (with support of IT)
- Interacts with all levels of organization, including internal management across functions and business units
- Evaluates audit responses for adequacy, including root cause, timeliness as well as utilizes and support knowledge to facilitate appropriate corrective action
- Resolves complex issues and escalates concerns through business and Quality Compliance Management, as appropriate
- Serves as a MDSAP consultant/subject matter expert and provides researched and supported opinions to MDSAP issues, support sites in improvement of identified issues
- As needed participates in and/or supports preparation of regulatory agency inspections (other than MDSAP) and/or responses to external observations
- Participates in other special projects as needed

Requirements:

- Bachelor's Degree in Science or Engineering discipline
- Minimum of 2 years' relevant experience in Quality, Compliance, Manufacturing or Engineering
- Experience in medical device area is a plus.
- General (not advanced) project management knowledge is required (ability to plan/manage/follow up/report etc)
- Good communication and presentation skills.
- Ability to interact with all levels of organization
- Positive attitude and good team player
- Fluent in English, any other language is a plus