Quality Assurance Specialist
4 weeks ago
The Quality Assurance Specialist will be responsible for improving quality within production to meet customer needs and expectations. This role will focus on process and equipment improvements, developing quality control systems and processes, and addressing quality system failures through effective root cause analysis methods and continuous improvement through effective CAPA.
Key Responsibilities- Participate in the investigation of technical problems, status of testing, establishment of procedures, and CAPA to avoid recurrences
- Lead quality-related problem-solving and root cause analysis in manufacturing
- Conduct supplier and construction surveys, audits, and inspections for system and product conformance to quality requirements
- Coordinate quality initiatives, perform internal audits, and update/write SOPs, and assist with Quality Senior Specialist with proper training and quality awareness
- Operate independently, representing the quality organization at major meetings to resolve important issues or plan work
- Coordinate all related teams to find solutions for Non-Conformance and initiate Non-Conformance management loops to reduce scrap and improve First Pass Yield (FPY) of manufactured products
- Quality problem identification in production and test, lead the whole problem-solving process to find the root cause and evaluate the effectiveness and follow-up the implementation of actions to both internal and external (customer) teams
- Work with appropriate groups to identify key quality metrics and help develop new quality metrics if needed
- Systematic quality data analysis to find improvements to develop, execute, and analyze quality procedures, standards, and measurements
- Promote compliance with Bright Innovation Labs' policies, procedures, quality standards, and current Good Manufacturing Practices (cGMP), as well as safety and environmental regulations
- Strong knowledge of relevant software, quality assurance methods, tools, and quality manufacturing processes
- Highly analytical, critical thinking skills, and problem-solving skills
- Ethics, high integrity, and professional behaviors
- Interpersonal skills such as active listening, respect, and great attitude
- Written and verbal communication
- Must be able to speak, read, and write in English, Spanish a plus
- Experience using Microsoft Word, Excel, and Outlook
- Ability to multi-task
- Flexibility with schedule including shift work
- Overtime may be required with very little notice
- Must successfully pass a background check and drug screen
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is usually moderate.
Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
The employee frequently is required to walk; and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit; and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus.
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