Troubleshoot issues during production to ensure rotor production quality
Conduct investigations of out of specification (OOS) and nonconformance events and yield loss incidents; perform root cause analysis and generate investigation / assignable cause reports and CAPAs as appropriate
Track and trend production failure modes; publish Pareto and trend analysis reports to generate focus on significant improvement opportunities
Lead continuous improvement activities including SIPOC product mapping, defining CTQ process steps, and establishing or updating DOPs and SOPs
Author and conduct DOEs, assist with validations, and work on similar special assignments with minimal supervision, including leading and directing work of others
Candidate preferred that has flexible schedule to work an assigned shift that includes some weekends
Minimum two (2) years experience within a Quality Control function in a medical device field
Strong technical scientific and laboratory skills including statistical analysis, experimental design, lab protocols/reports, calibration, lab safety, bio-hazard and chemical handling, and diagnostic product performance knowledge
Hands-on experience and demonstrated good judgment in troubleshooting complicated products
Proficient computer skills such as Excel, Word, MS Visio, JMP, Minitab, or similar software
Fast learner with excellent written and verbal communication
Demonstrated organizational, prioritization, and time management skills
BS/MS in Biological/Chemistry/Chemical Engineering or related field
Process Excellence training preferred
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