Type: Direct Hire
Shift: Monday-Friday 7/7:30am
Location: Commerce, California
Objective: The Quality Validation Engineer is responsible for the quality control of our product design and manufacturing process control.
Requirements:
• Bachelor’s degree in engineering or related discipline.
• 1-3 years of validation experience
• Quality experience (risk analysis, CAPA, root cause analysis, FMEA, lean six sigma, audits, corrective actions).
• Validations experience (IQ/OQ/PQ, test method validation
• Experience with GMP, quality systems, ISO13485
• Experience with medical instrumentation (ISO9001, ISO13485)
Responsibilities:
• Use of statistical tools to facilitate design verification test sample size and test method validations.
• Lead Risk Analysis (FMEA-CA Design/ Process) meetings and generate final reports and actions requirements.
• Perform analyses of failed material in order to determine the root cause. Implement appropriate corrective actions.
• Work on new product transfers and actively participate in the qualifications and validations of product/ equipment and processes.
• Review and approve document changes (process and design).
• Assist R&D in test method development and conduct test method validation.
• Participate on internal quality audits.
• Develop and implement quality systems in compliance with ISO certification.
• Review and approve receiving inspection requirements and sampling plans for components. Develop and improve QC inspection and testing method as needed.
• Backfill quality review, QC testing, receiving inspection and product release activities as required.
• Support the implementation of overall company validation strategy
This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
