quality engineer [medical device].

Our client is a global medical device manufacturer leading the charge in healthcare innovation. They offer a fast-paced, high-tech environment with structured career pathways designed to accelerate professional growth for ambitious Quality Engineers obsessed with precision and excellence.

about the job

• Lead quality planning for new projects, establish product line control plans, and author inspection specifications for raw materials, in-process production, and finished goods.
• Oversee in-process and finished product inspections, conduct compliance reviews of batch records, and ensure the accuracy, traceability, and archiving of Device History Records (DHR).
• Manage non-conforming or detained products efficiently and conduct regular cleanroom audits to drive strict GMP compliance.
• Facilitate cross-departmental meetings to investigate quality incidents, adverse events, and customer complaints using root cause analysis to track NCR and CAPA closures.
• Perform regular statistical analysis on product line quality performance metrics to identify trends and propose data-driven continuous improvement initiatives.
• Support internal and external regulatory/customer audits, while training QC personnel on inspection standards, equipment operation, and general quality awareness.