Quality Engineer

Universal Scientific Industrial Co., Ltd.; Milpitas (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

Universal Scientific Industrial Co., Ltd. seeks a quality assurance professional to ensure safety and quality through rigorous inspections and QC measures.

You will collaborate with cross-functional teams to drive continuous improvement and build high-quality products that meet customer expectations. The role requires a background in engineering or quality assurance, exceptional attention to detail, and a proactive mindset.

Qualifications

• Background in engineering or quality assurance.
• Excellent attention to detail and proactive mindset.
• Communicates issues and suggests process improvements to management.
• Collaborates with manufacturing engineers and signs off on IQ, OQ, PQ, and APQP milestones.
• Conducts data trend analysis and statistical analyses.
• Leads customer QBRs to present quality results.
• Audits systems against ISO requirements.
• Determines and signs off quality metrics for manufacturing instructions.
• Ensures training is completed and documented.
• Monitors production cycle to identify potential malfunctions early.

Responsibilities

• Communicate significant issues identified during QA activities and provide recommended process improvements to management.
• Lead the customer complaints and initiate a CAPA.
• Perform data trend analysis and statistical analyses.
• Lead customer QBRs to present quarterly quality results.
• Audit our systems based on ISO requirements and sign off quality metrics.

Skills

Engineering background

Quality assurance

Attention to detail

Proactive mindset

QA leadership

Tools

APQP

PPAP

CAPA

ECO/ECR

Job description

You will be responsible for ensuring the safety and quality of our products and procedures through rigorous inspections, implementation of quality control measures, and identification of areas for improvement. You will collaborate with cross-functional teams to address quality issues, drive continuous improvement, and contribute to building high-quality products that exceed customer expectations. As well as, have a background in engineering or quality assurance, exceptional attention to detail, and a proactive mindset.

• Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
• Work with manufacturing engineer and sign off on IQ, OQ, PQ, PPAP, Advanced Product Quality Planning, and APQP, master validation plan (MVP) and device manufacturing history and tracking data.
• Lead the customer's complaint and initiate a CAPA.
• Perform data trend analysis, participate in Phase Reviews, write Quality Procedures, perform data/statistical analysis.
• Lead the customer QBR's to present and explain quarterly quality results.
• Verify data integrity, revision level, ECO, ECR, deviations, process alert, and data sheet validations.
• Audit our systems based on ISO requirements.
• Determine and sign off quality metrics for all manufacturing process instructions.
• Ensure the necessary training is done and documented.
• Communicate closely with customers. monitor the entire production cycle and perform regular reviews to identify potential malfunctions as early as possible.