- 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 customers complaint and initiate a CAPA.
- Perform data trend analysis, participate in Phase Reviews, write Quality Procedures, perform data/statistical analysis.
- Lead the customer QBRs 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.
- Identify the root cause of technical issues and recommend fixes and use quality tools to find the root cause of problems.
- Perform pFMEA with all departments to identify the risk and the mitigation plan.
- Initiate internal and external 8D CAPA and SCARS. Led the team to close internal CAPAs and external SCARS.
- Be familiar with none conformance, RMA, and MRB
- Set and track quality goals by analyzing SPC, CP, CPK, and G R & R calculations.
- Read and be familiar with customers electronics, electrical, and mechanical blueprints.
- Act as a leader to work with internal teams to increase customer satisfaction by improving the quality of the products.
- Be flexible if other duties as assigned.
- BS Degree level of knowledge that would be obtained from a BS degree.
- Minimum of 5-10 years experience in the following areas:
- Experience as a Quality Engineer in an Electronics Manufacturing Environment.
- Experiences with contract manufacturing on PCBA and system full product assembly.
- Experiences with medical devices, auto PPAP, IATF, AOI, AXT, ICT, and FT.
- Attention to detail
- Problem-solving skills
- Engagement
- Leadership
- Communication
- Teamwork
- Training skills
- Speaking and writing fluently in English
- ISO 9001
- ISO 13485
- TS 16949
- ISO 14001
- IPC-610 Workmanship Standards
- J-STD-033A (MSD Handling)
- ANSI/ESD S
- PPAP
- APQ
- MVP
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Senior Quality Engineer - Fremont, United States - Universal Scientific Industrial Co., Ltd.
Description
USI/Asteelflash is actively looking for a Senior Quality Engineer to join our Quality Team here in Fremont, CA.
The successful candidate 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.
RESPONSIBILITIES:
MINIMUM QUALIFICATIONS:
Experience with quality standards, including the following:
The expected base salary range for this position, if filled in California, is $100,000-$120,000 annually, dependent on specific skills and work experience.
To formally apply for this position, please submit your resume to
Please refer to REQ# R when submitting your resume.
