DIRECT HIRE - QA Engineer

Must Have:

• Medical Device experience
• Class A ISO 1485 experience

Key Responsibilities:

• Ownership of all aspects of Quality Assurance and Quality Control.
• Measure, test, evaluate, and document product performance to assure compliance with appropriate customer and company specifications including Verification, Validation and Qualification testing.
• Inspect products, perform failure and quality related analysis that relies on Quality and Manufacturing principles, including process management, statistical analysis, and human factors.
• Work with lab equipment including oscilloscopes, signal analyzers, & signal generators.
• Plan the Quality workload, including scheduling and charting (including PERT/CPM, Pareto, Gantt, etc.), identification of resource requirements, risk, and oversee execution to the plan.
• Lead the resolution of customer and internal issues regarding product quality, with the aim of achieving zero defects.
• Conduct internal, ISO 13485 & 9001:2016, or supplier auditing when required.
• Support ISO 13485 & 9001:2016 certification and customer auditing.
• Troubleshoot and perform root cause analysis to develop timely, appropriate responses and alternate solutions to customer product problems and questions, while generating formal reports and corrective actions.
• Lead continuous improvement and other initiatives which require cross functional team.
• Create and implement company policies, procedures, specifications, and end user documentation.  Immediately correct all documents where the written document differs from the actual practice.
• Advise on and/or oversee the implementation of product development workflows and production workflows.
• Work with engineering to address hardware/software concerns /upgrades as needed.