Specialist Quality LIne

Specialist Quality Line

Manage all aspect of quality on the product line

Lead Quality Emergency situation (QA crisis management) for the scope of responsibility, with support of other departments. 

Key responsibilities

• Ensure compliance to all work instructions in place on the manufacturing line and perform regularly 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 perform investigation on any 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 anytime significant change occurs on a process. In scope of this SQL operational function, Update VMP accordingly
• Participate to Process Validation and Change Control lead 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
• 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.

Profile requested

• 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

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