Quality Engineer 2

The Quality Engineer II supports product and process quality within regulated environments such as medical device, biotech, or pharmaceutical manufacturing, focusing on validation processes and ensuring compliance with FDA and ISO regulations.

Requirements

• Provide quality and validation leadership to new product development teams
• Develop and maintain master validation plans, validation protocols, and validation reports
• Execute and document validation activities including analytical method validation, equipment qualification, facility/utility qualification, process validation, cleaning validation, and raw material qualification
• Review document change orders and change control requests for completeness, quality impact, and validation impact
• Determine validation strategies using a risk-based approach
• Lead or support cross-functional teams in developing and maintaining Process Failure Mode and Effects Analysis (PFMEA)
• Conduct risk assessments for process-related non-conformances and planned deviations
• Maintain validation documentation and records
• Support New Product Introduction (NPI) and sustaining product projects
• Review regulatory submissions and notifications as needed
• Identify and propose process or quality improvement projects using supporting data and analysis
• Develop or update departmental procedures and controlled documents
• Evaluate the adequacy of specifications for new or modified process designs
• Lead departmental and cross-functional projects, define deliverables, and support project timelines
• Participate in process design reviews
• Support Material Review Board (MRB) and Production Response Team (PRT) meetings
• Contribute to departmental process improvement initiatives and quality metrics
• Provide regular status updates to management and escalate issues when necessary
• Train new employees

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Tuition Reimbursement