Website LanceSoft Inc
LanceSoft Inc
Company : LanceSoft Inc
Join our team in Tempe, AZ, a vibrant city known for its innovation and technology-driven environment. You will play a critical role in ensuring the quality and compliance of process development and manufacturing of implantable electronic products.
Must Have
- Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.
- Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.).
Nice to Have
- Experience with electronics manufacturing including wafer fabs and electronics assembly.
- Six Sigma or DRM certification.
- Strong statistical analysis techniques.
Responsibilities
- Ensure internal quality processes, procedures and systems are compliant to all governing standards.
- Support manufacturing development and continuous improvement as the Quality team member for process development and validation.
- Use knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing engineers in the development of compliant test plans and reports.
- Support risk assessment processes for manufacturing and development including process FMEA and design FMEA.
- Support CAPA investigations, improvements, and effectiveness verification testing.
- Lead and/or support investigations of non-conforming product, materials, or processes through the coordination of cross-functional teams.
- Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics.
Top 3 Technical Skills
- Strong understanding of operations/manufacturing processes and products.
- Ability to work independently and provide comprehensive feedback on complex issues.
- Strong communication skills (verbal and written).
Education and Experience
- Education Required: Bachelor’s degree.
- Years’ Experience Required: 4 years’ work experience.
Work Schedule and Location
- 40 hours per week, onsite at our Tempe, AZ campus.
Product Line Support
- Wafer and Sensor Operations and Hybrid product lines.
This position is short term through May 2026 and will most likely not get extended. We are looking to schedule interviews ASAP. Join us to make a significant impact in a dynamic and fast-paced environment!