Ww Complaint 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 **BD Medical - Pharmaceutical Systems** WW Quality System team, The WW Complaint 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:

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

**Main responsibilities**:

- Manages merged investigation reports when several sites are involved as well, as assigned, task in Global Complaint System.
- Recommendation on complaint triage, re-opening decisions and sample analyses requests.
- Trains and Mentors all BDM - PS Investigators at all BDM - PS Sites and ensures process efficiency 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
- 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.
- 3-5 years' experience in investigation and resolving quality related matters
- High proficiency of English is required
- 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**: