93 applicants
LT · 3 days ago
Quality Engineer
USA
Full-time
Onsite
Senior Level
5+ years exp
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Responsibilities
Lead new product introductions and ensure successful transition to manufacturing
Provide Quality engineering support for the development and manufacturing of new products
Develop and establish robust, repeatable, and reproducible processes
Represent Quality engineering in cross-functional teams
Perform process validations (IQ/OQ/PQ)
Monitor, evaluate and report project progress and results
Prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis
Perform root cause analysis of product/process issues and implement short and long-term corrective actions to improve product quality
Prepare technical and validation protocols, written reports, documentation, and engineering change notifications
Provides technical supplier management support as related to product development and introduction
Analyze and plan workforce utilization, space requirements, and workflow and designs layout of equipment and workspace for maximum efficiency
Confer with vendors to determine product specifications and arrange for purchase of equipment, materials or parts and evaluate products according to specifications and quality standards
Estimate production times, staffing requirements, and related costs to provide information for management decisions
Confer with management, engineering, and other staff regarding production capabilities, production schedules, and other considerations to facilitate production processes
Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, cGMP and all other applicable agency regulations
Lead functional and cross-functional teams to achieve project goals
Mentor junior manufacturing engineers in project management activities
Qualification
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Required
Bachelor’s Degree or higher in biomedical, mechanical, industrial or similar discipline
Minimum of five (5) years related experience in FDA/GMP regulated industry
Proficient in SolidWorks, Minitab, Word, Excel and Project
Experience in product development and manufacturing methods, procedures, and cost reduction/yield improvement techniques
Background in medical device assembly, automation, and vision system technology
Experience in the application of statistical techniques such as statistical process control, design of experiments, and problem-solving techniques is required
Experience with design, review, execution, and approval of Installation, Operation and Process Qualification protocols and reports (IQ/OQ/PQ)
Company
LT
Lions Trust is a Brazilian independent fund administration provider, specialized in the alternative fund industry, like Private Equity, Venture Capital, Seed Capital, Timber and Infrastructure.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase
