Design Assurance engineer- SUD

Onsite Key Responsibilities

• Lead departmental and cross-functional engineering initiatives
• Direct, coach, and mentor engineering/technical staff on projects
• Research and implement best-in-class Quality Engineering practices
• Provide technical guidance for resolving quality issues
• Design and implement process controls to support product development, qualification, and manufacturing
• Lead implementation of CAPA systems and quality assurances
• Support quality decisions and practices as a leader or team member
• Use structured problem-solving to identify, prioritize, and resolve quality issues
• Build streamlined systems to catch and fix quality issues early

Quality System Requirements

Demonstrate commitment to patient safety and product quality by following the Quality Policy and related procedures at all times.

Job Scope & Leveling Guidelines

• Functional Knowledge: Strong technical/conceptual knowledge in own field; general awareness of related functions
• Business Expertise: Understands key business drivers and how related teams work together to improve efficiency
• Leadership: Leads by example; coaches and gives feedback; May lead small projects with manageable risk
• Solving Problems: Solves problems of varying complexity, mostly using existing solutions; Uses judgment to propose alternatives or new solutions when needed; Works independently, seeking guidance mainly on complex or new problems
• Affect on Quality: Affects quality/effectiveness within own team and related teams; Has some influence on broader organizational goals
• Interactions & Communication: Shares complex information, sometimes guiding or persuading others; Regularly presents in small, cross-functional meetings