Sr. Quality Engineer
Core
Drive continuous quality improvement by developing and maintaining a certified QMS, conducting root cause analysis, and ensuring designs meet cross-functional requirements for manufacturing and supply chain.
Role type
Senior IC Quality Engineer (Manufacturing)
Builds
Certified QMS to ISO 9001:2015, robust inspection/verification test strategies, IQ/OQ/PQ qualifications, and quality control plans.
Domain
Industrial manufacturing / Energy (Plug Power)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality Assurance & Compliance)
Required skills
ISO 9001:2015, 8D, Lean, 5 Why's, Pareto Analysis, Six Sigma, regulatory compliance (UL, IEC, CE, GSA, CSA, FCC, RoHS, REACH), mechanical drawing reading, machining knowledge, assembly practices, root cause analysis, complaint investigation, failure analysis, NPI support, ECO process, IQ/OQ/PQ execution.
Preferred skills
None explicitly stated as preferred, only required.
Technologies
Microsoft Office, 5Why, Fishbone diagrams, ISO 9001:2015, ISO13485.
Responsibilities
Develop and maintain a certified QMS to ISO 9001:2015; Conduct QMS audits to drive process standardization and compliance; Lead complaint investigations and failure analysis using root cause analysis methods; Collaborate with design engineers to develop inspection and verification test strategies; Support product development and new product introduction (NPI) with benchmarking and capability assessments; Review design specifications and outputs to confirm quality requirements prior to manufacturing transfer; Provide training and support to operations personnel; Mentor members of the Ops QA Team.
Seniority
Senior, hands-on IC with mentorship responsibilities.
