Design Quality Engineer

The Design Quality Engineer II provides Design Quality Engineering support to ensure the successful development of Cooper products and ongoing operational support, applying knowledge of design control principles and quality engineering techniques to support development efforts and address quality-related challenges. This role is responsible for ensuring products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer expectations, and reviews and evaluates scientific and technical data related to product development and testing, contributing to problem-solving activities for product and process improvements, while collaborating with cross-functional teams and providing guidance when appropriate.

Responsibilities

• Quality Representation
  • Actively represent Quality function on product/process development teams. 
  • Support engineering teams to ensure design control requirements are met effectively, including design verification, validation, specifications, procedures, risk management, and design reviews. 
• Supplier Engagement
  • Support supplier tooling activities to help ensure components are qualified on time, including use of PPAP tools. 
  • Participate in supplier selection activities and specification reviews to help ensure purchased components meet requirements. 
  • Collaborate with Engineering to define quality characteristics and inspection plans for components, subassemblies, and finished devices. 
• CAPAs/Non conformances
  • Participate in investigations of product and process issues; contribute to root cause analysis and corrective actions. 
  • Support evaluation and disposition of nonconforming materials used in development, pilot, or clinical builds in accordance with quality system requirements. 
• Design 
  • Participate in design reviews to evaluate designs and provide quality-related feedback. 
  • Contribute to early stages of product development, including prototype evaluation, testing, and cross-functional collaboration. 
  • Provide input to design and manufacturing documentation (e.g., specifications, drawings, inspection procedures) to support manufacturability and testability. 
  • Contribute to development of design input requirements based on prior product knowledge, historical issues, and competitive insights.
• V&V
  • Support development of the master test plans (I.E. trace matrix, VMP….) that encompass design verification, design validation and process validation activities. 
  • Contribute to development, evaluation, and validation of product and process test methods. 
  • Review test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.