Description

You will lead initiatives to assess, develop, and enhance product and supplier quality. You'll collaborate with R&D and Engineering on new product transfers, manage supplier quality, and drive continuous improvements in instrument manufacturing processes.

Requirements

• Bachelor's degree in Mechanical Engineering (or equivalent)
• Demonstrable experience in complex instrumentation or electro-mechanical system manufacturing within the Life Sciences or Medical Device industry
• Strong technical understanding of precision assemblies, motion systems (X-Y stage), instrument fixtures and testing tools
• Proven experience working with contract manufacturers and managing supplier quality and performance including participation in NPI cycles
• Experience in supplier development or Supplier Management/Vendor quality system enhancement
• Understanding of ISO 9001 and/or ISO 13485 quality management system requirements
• Knowledge of CAPA, nonconformance, deviation and SCAR management
• Strong problem-solving and analytical skills
• Excellent communication and collaboration skills

Responsibilities

• Collaborate with R&D and Engineering to ensure product meets quality, manufacturability and reliability requirements from pilot build through production
• Provide quality oversight and guidance to internal teams and contract manufacturers throughout new product introduction and production transfer
• Partner with contract manufacturers and key suppliers to ensure product and process quality meet requirements
• Assess, develop, and continuously improve supplier quality systems
• Conduct supplier audits, process reviews and performance monitoring using quality metrics and KPIs
• Lead root cause analysis and corrective action implementation for supplier-related issues, including SCAR management
• Lead investigation and resolution of nonconformances, deviations and manufacturing issues
• Support customer complaint investigations related to instruments
• Drive ongoing quality improvements in instrument assembly processes
• Support development and continuous enhancement of quality procedures, documentation and control processes
• Track and analyze key quality metrics to identify trends and drive preventive actions
• Support internal and external audits, qualification and regulatory compliance efforts
• Lead and participate in cross-functional quality improvement projects