As an Operations Quality Engineer at the Ops QA department you will be responsible for Leading and maintaining product quality plans activities throughout product life cycle, from design transfer to post market.
You will:
Champion problem solving and root cause analysis activities in production line to eliminate recurrence of non?conformances.
Serve as quality liaison for production line and ensure corporate standards, procedures and tools implementation and compliance
Serve as subject matter expert for manufacturing engineering processes such as process validation, MSA, pFMEA etc.
Lead and support sustainability and improvement projects
Monitor, communicate and seek improvement of quality KPIs
Lead and participate in internal and external audits
Communicate manufacturing quality standards and requirements.
Requirements:
Must Have:
Minimum 3 years of experience as quality engineer in the Medical. device/aerospace/pharma industry.
Electrical/Mechanical/Biomedical/Quality Engineer.
Knowledge in Medical device standards and Regulations (ISO13485, QSR, MDR, ANVISA etc.).
Good control in statistical techniques.
Experience with 8D, Lean, 5 Whys, Pareto Analysis, Six Sigma, 8D, DFSS, dFMEA, pFEMA, PPAP, Process Validation etc.