Quality Assurance Specialist APlus International Chino, CA Job Details Full-time $60,000 - $65,000 a year 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off 401(k) matching Qualifications Statistics English Research Attention to detail Data-driven problem-solving Chinese FDA regulations

Full Job Description Job Title:

Quality Specialist Position Summary We are seeking a detail-oriented Quality Specialist to support our Quality Assurance team. This position will be responsible for reviewing quality and technical documentation, assisting with validation activities, maintaining quality records, supporting investigations, and coordinating quality-related projects with internal teams, customers, and manufacturing partners. The ideal candidate is highly organized, attentive to detail, comfortable reviewing technical documents and data, and able to communicate effectively in both English and Chinese . Key Responsibilities Review quality, validation, and technical documentation for accuracy, completeness, and compliance. Assist with process validation activities in accordance with FDA Process Validation Guidelines, including sterile pouch sealing processes using: Form-Fill-Seal (FFS) sealers Impulse sealers Rotary band sealers Support sterilization validation activities and related documentation. Perform statistical analysis and quality control using Excel, Minitab, InfinityQS, and other SPC tools. Assist with control charts, including X-bar and R charts, and process capability analysis. Support Corrective and Preventive Action (CAPA) investigations, documentation, implementation, and follow-up. Research and review technical standards and regulatory requirements, including: ASTM test methods ISO standards FDA regulations and guidance Industry technical publications Research and assist with quality engineering tools and methodologies, including DOE and FMEA. Work with customer accounts on special quality and validation projects. Coordinate with Project Management and other internal departments on technical and quality-related projects. Assist with customer complaint investigations, documentation, root cause analysis, and follow-up. Maintain organized and accurate quality records and ensure documentation is completed in a timely manner. Communicate with overseas manufacturing partners regarding quality documentation, testing, corrective actions, and project requirements. Qualifications Bachelor's degree in Quality, Engineering, Science, Manufacturing, or a related field preferred. Previous experience in Quality Assurance, Quality Control, medical devices, manufacturing, or a regulated industry preferred. Bilingual in English and Chinese required. Strong attention to detail and ability to carefully review technical documents and records. Strong written and verbal communication skills. Proficient in Microsoft Excel and Microsoft Office. Experience with Minitab, InfinityQS, SPC, CAPA, validation, or statistical analysis is a plus. Ability to manage multiple projects and deadlines while maintaining accurate documentation. Strong analytical, organizational, and problem-solving skills. Ideal Candidate The successful candidate will be someone who is meticulous, organized, and comfortable working with detailed documentation. This role is well suited for someone who enjoys reviewing information, identifying discrepancies, following established procedures, and working across teams to ensure quality and regulatory requirements are met.

Pay:

$60,000.00 - $65,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Paid time off

Work Location:

In person