Specialist Quality Production Line

Specialist Quality Line

Manage all aspects of quality on the product line. Lead Quality Emergency situation (QA crisis management) for the scope of responsibility with support of other departments.

• Ensure compliance to all work instructions in place on the manufacturing line and perform regular GMP audits to related topics Quality documentation, Work instruction, Calibration, Records.
• Manage quality hold related to the scope of responsibility, in collaboration with QH Specialist. Lead root cause analysis to investigate new quality defects or non‑conformities raised during MRB.
• Open non‑conformity (NC) in case of reoccurrence of significant quality issues (risk / occurrence / detection) as per standard in place. Review risk analysis and ensure PFMEA are up to date.
• Manage CAPA related to operational quality issue.
• Create Quality dashboard in collaboration with OLM or line supervisor. Review KPI and perform monthly trend analysis.
• Create and update defect list upon needs. Review and assess Line Quality System vs Standards and report any identified gaps to SHD.
• Lead Process validation according to procedures in place and ensure Change Control is applied whenever a significant change occurs on a process. In scope of this SQL operational function, update VMP accordingly.
• Participate in Process Validation and Change Control led by Transversal QA team on its line to support worst‑case Products / Parameters definition. Ensure communication of changes to operational teams.
• Participate with functional team to perform Process risk analysis (PFMEA). Ensure all operational actions defined in PFMEA are implemented and verified. Perform impact assessment of product modifications and compare to quality level of its line.
• Act as a coach for production team leaders on QH first level of investigation, and root cause analysis.
• Ensure respect of work instructions and GMP on its production line through regular practice.
• Ensure compliance in the implementation of Process deviation (SI), according to procedures. Alert QO or QA Supervisor if risk is identified and associated with a process deviation.

• Master degree level, Medical Device Quality or mechanical
• Internal auditor and green belt (a plus)
• 3 to 5 years in a QA department, in Medical device/Pharmaceutical/Automotive business
• QA tools as KPI Dashboard, PFMEA (risk analysis)
• Problem solving tools as DMAIC, 5 Whys, KAIZEN
• Statistical tools as R&R, SPC, Variance analysis
• Language:
  French (min level C1), English (min B2 level)
• Leadership, initiative and teamwork

Dentsply Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law.

All successful applicants must be eligible to work in the country the position is based.