As a member of the Product Robustness Team, this role ensures the quality and continuity of incoming materials through process definition, improvements, QC strategies and failure investigations. This function ensures effective transfer of requirements and changes to and from suppliers. An ideal candidate will drive product robustness and performance excellence by building solid quality criteria for incoming materials from Accelerate Diagnostics suppliers.
Drives continuous process improvements at suppliers focusing on quality, capacity, and cost reduction
Serves as technical liaison to between suppliers and internal teams to develop new products
Ensures bi-directional communication of requirements and changes
Develops goals and metrics to monitor supplier performance requirements
Produces reports and presentations tracking vendor performance
Conducts and participates in supplier related failure investigations
Qualifications, Experience and Skills
BS in Engineering, Chemistry, Life Sciences, or related scientific field
Minimum of 3 years' experience in medical device manufacturing, or similar industry
Familiar with implementation of quality systems
Skilled in root cause analysis and long term CAPA resolution
Knowledge of trending and SPC
Verification and validation for 13485 / cGMP compliance
Familiar with lean principles, Six Sigma Black Belt desirable
Accelerate Diagnostics, Inc.