Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements
Job Summary
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
Matching Summary
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Skills & Requirements
Must-have
Quality improvement initiatives
Process and product characterizations
Compliance to QSRs, ISO 13485
Design controls and risk management
Non-conformances, CAPAs, customer complaints
Product/Process Validation (IQ, OQ, PQ)
Process monitoring and control methods
Nice-to-have
Continuous cost improvements
Benchmarking for quality methods
Cross-functional collaboration
Root cause investigation
Leading and lagging indicators of quality
Risk mitigation techniques
Key Requirements
Quality engineering experience
Experience with quality tools (PDCA, Six Sigma, Kaizen, Lean)
Familiarity with medical device regulations (QSRs, ISO 13485)
Experience with validation/verification documents (IQ, OQ, PQ)