New

Quality Engineer

Spectraforce Technologies
United States, California, Santa Clara
Nov 13, 2024
Job Title: Quality Engineer IV Duration: 12 Months Work Location: Santa Clara, CA, 95054 Shift timing: 8am - 5pm Job Description: Consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations and Product Performance Analysis teams to ensure compliance to LifeScan software development procedures and industry regulations. They support their RA organization and their business unit from a quality and compliance perspective. Looking for someone with quality systems experience who has senior level expertise. Activities they do is supporting audits for RA manage all CAPA's for RA organization. Key task for this role is putting together a KPI dashboard maintaining that from a compliance perspective to keep a pule on metrics that they have. Highlight risks if they see them and put in mitigation plans before they become audit findings or nonconforming results in CAPA related activities. Supports management and creation of the processes that allows the RA specialist to execute those submission requirements. Review and approve deliverables of the software development lifecycle. Lead teams in performing Hazard Analysis. Occasionally assist teams in developing Standard Operating Procedures and Work Instructions for software development activities that meet their specific needs. Occasionally provide training for select software development activities for LifeScan. Occasionally write and execute test protocols and reports. 7+ years Soft skills Independent good clear communication skills, team player, there will be a lot of international cross function interactions. Good project management skills. Problem solving expertise. Education: Bachelors Degree Experience: 7+ years of experience