Provide QE support to product development teams (Design Controls)
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.
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.
2-5 years exp
Main responsibilities:
Authors and reviews/approves protocols and report to support Design Controls deliverables
Performs data analysis to support product development studies
May be responsible for creating risk assessment documentation
May be responsible for test method validation
Develops/implements process monitoring requirements and documentation
Identifies and controls Manufacturing process defects by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions
Creates product specifications, quality specifications and quality plans in conjunction with other product development team members
Plans, organizes, and prioritizes own daily work routine to meet established schedule
Skill Set
Medical device regulation/guidance (FDA, ISO)
Risk management
Test method validation
Design Verification (Filing and Aging studies)
Process validation
Data analysis (JMP)
Seniority level
Entry level
Employment type
Contract
Job function
Design, Art/Creative, and Information Technology
Industries
Medical Equipment Manufacturing
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