Senior Quality Manager

3 days ago


Minneapolis, Minnesota, United States Olympus Corporation of the Americas Full time

We are seeking a Product Quality Engineer to join our team at Olympus Corporation of the Americas. This role will be responsible for the design, development, and management of projects for legacy products.

Job Description

The Product Quality Engineer provides organizational support with a focus on Design Quality activities. Works with internal/external manufacturers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies and procedures and medical device regulations.

Key Responsibilities:
  • Drive the design & execution of Production Release Process project for components & finished devices
  • Lead and implement complex projects including quality improvement initiatives
  • Sets direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems
  • Lead Process/Design Risk Analysis
  • Provide leadership in understanding of the quality regulations to other disciplines
  • Lead multiple product Design Control activities for new product development efforts
  • Support Process/Design Validation Nerification activities and approach including software validation
  • Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting
  • Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing

This is an exciting opportunity to work with a dynamic team and contribute to the development of innovative medical technologies that improve patient outcomes.



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