Product Quality Engineer
Core
Owns and drives the quality performance of manufacturing processes, ensuring they meet regulatory and product requirements.
Role type
Manufacturing Process Quality Engineer
Builds
Manufacturing processes and quality control plans
Domain
Medical devices / Regulated manufacturing
Required skills
Root-cause analysis, Process validation, PFMEA, Control Plans, CAPA, Statistical process control, 8D problem solving, DMAIC, Audit participation
Preferred skills
Medical device industry experience, Change management, NPI support, Supplier quality collaboration
Technologies
5-Why, Fishbone, 8D, DMAIC, KPIs (FTR, DPU, DPMO, Yield)
Responsibilities
Monitor process quality performance using KPIs, Identify process quality risks and lead initiatives to reduce variation, Perform structured root-cause analysis of manufacturing defects, Lead investigation of Non-Conformances and Quality Notifications, Define and implement corrective and preventive actions, Support process validation and re-validation activities, Establish and monitor process quality control plans, Participate in internal and external audits
Seniority
Mid-level, hands-on IC