Staff Investigator

**Job Description Summary**: With innovative pre-fillable syringes, self-injection systems, safety systems and needle technologies, the Pharmaceutical Systems (PS) team offer an extensive selection of solutions designed to protect, package and deliver drug therapies.

Member of the Designated Complaint Handling unit within BDM - PS WW Quality System team, The Staff Investigator ensures the complaint process is managed end-to-end by meeting internal and external expectations for all complaints related to BDM-PS products, with a continuous improvement approach. The scope being:

- Driving the complaint process to be a center of excellence with customer satisfaction on investigation and complaint closure.

**Main responsibilities**:

- Recommendation on complaint triage, re-opening decisions and sample analyses requests.
- Streamlines sample management process and interactions with all actors
- Trains and Mentors all BDM - PS Investigators at all BDM - PS Sites and ensures process effectiveness with all associates
- Interacts with product development teams to establish complaint package for transferring new and major product design changes from development team to complaint team
- Lead cross functional teams and completes corrective actions for identified issues
- Manages merged investigation reports when several sites are involved as well, as assigned, task in Global Complaint System.
- Works with Quality Engineering to link complaints to risk management files
- Supports Post Market surveillance process
- Presents DCHU activities during Complaint Management governance forum.
- Interacts during audits/inspections with Notified Bodies, Health authorities and customers.

**Profile**:

- Engineer or Pharmacist or similar scientific discipline.
- Extensive Technical and quality knowledge in particular on BDM - PS products, complaint management and investigation processes / Technical writing / Statistical Methods
- Knowledge of Medical devices regulations (ISO 13485 / 21CR820) and pharmaceutical products
- Experience with Trackwise and SAP

**Primary Work Location**: FRA Le Pont-de-Claix Cedex

**Additional Locations**:
**Work Shift**: