Staff Systems Engineer for Infleqtion, leading multidisciplinary R&D projects in quantum technology including NASA's Quantum Gravity Gradiometer program.
About the role
- Labeling Systems Engineer sustaining and maintaining labeling system software and hardware for medical device manufacturing. Collaborating on compliance and quality assurance for labeling processes.
Responsibilities
- Sustain and maintain labeling system software, hardware and processes in medical device manufacturing
- Develop next iterations of a complete labeling system (software, processes and equipment)
- Ensure quality and compliance of medical device labeling and manage internal and external databases
- Perform validation activities (software and hardware) and manage departmental work instructions/processes
- Deploy labeling solutions and guide blueprinting, validation, process design, and implementation of software, hardware, and processes
- Ensure timely change management of labeling and Instructions For Use (IFUs)
- Collaborate with quality management and all life-cycle phases of product labeling and IFUs
Requirements
- Bachelor’s Degree in a related field
- 2+ years of experience in System Architecture, System Design or equivalent
- Experience in software or process design/validation in a regulated environment
- Labeling experience in a regulated industry is strongly preferred
- Skills include validation testing, technical documentation, technical acumen, quality specifications, and continuous improvement
Benefits
- PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
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