Description

In this role, you will actively shape product quality by defining metrics, leading initiatives, and guiding engineers on best practices. Your day-to-day responsibilities will involve analyzing failures, supporting manufacturing processes, and ensuring compliance with quality standards.

Requirements

• •Bachelor’s degree in electrical, mechanical or system engineering, math, or physics
• •Advanced degree preferred
• •5+ years of working experience in Quality Engineering or Process Engineering
• •Minimum 3 years in medical device design or manufacturing environment
• •Ability to navigate quality and compliance system with minimal oversight
• •Understanding of CFR 21 820/ ISO 13485 requirements
• •Experience in generating FMEA and process FMEA
• •Understanding of Design Controls and Change Controls
• •Proficiency in generating and executing Qualification and Validation protocols
• •Experience in leading product containment and rework activities
• •Proficiency in SPC & Six Sigma methodology and tools
• •Experience in typical Excel data analysis operations
• •Ability to create multi-source reports and interpret data with minimal oversight
• •Ability to think independently and make decisions based on limited information
• •Ability to initiate improvement discussions and lead teams
• •Ability to present information in various forms and forums
• •Excellent creative problem-solving skills
• •Excellent communication and documentation skills in English and German

Tasks

• •Define quality metrics and specifications
• •Identify opportunities for product improvement
• •Launch quality initiatives and lead implementation projects
• •Consult on complex quality problems
• •Handle projects across various product types
• •Develop measurable quality goals
• •Lead Quality Table meetings
• •Mitigate performance aspects in product quality plans
• •Recommend design processes to meet quality goals
• •Guide engineers on regulatory requirements
• •Create quality standards and assurance procedures
• •Design comprehensive procedures for quality data
• •Analyze and disposition discrepant materials
• •Support manufacturing processes and failure analysis
• •Review and approve documentation
• •Qualify tooling and inspection methods
• •Develop process validation and verification plans
• •Support manufacturing line qualification plans
• •Provide quality expertise for product failure analysis
• •Perform deep technical failure analysis
• •Review complex data analysis related to product performance
• •Create and review Quality Notifications and Change Orders
• •Develop corporate quality metrics
• •Lead quality meetings and initiatives
• •Conduct mock audits and Gemba walks
• •Participate in audits
• •Communicate intercompany Quality Engineering projects

Tools & Technologies