Overview
Quality Assurance Engineer Jobs in Maple Grove, MN at REQ Solutions
Title: Quality Assurance Engineer
Company: REQ Solutions
Location: Maple Grove, MN
Job Title: Design Quality Engineer
Duration: 12+ Months (Possible extension)
Location: Maple Grove, MN 55311
Hybrid Role
Responsibilities:
The Design Assurance Engineer will interface with R&D and other supporting cross-functional teams on developing and maintaining medical equipment, including software and cybersecurity elements.
Design assurance drives the ISO 14971 risk management process, Verification & Validation (V&V) process.
This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems/procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports.
Interfaces with all other quality and engineering components within the company and with customers and suppliers on quality-related issues.
Actively participate in all aspects of Design Control, including capital equipment, systems, and software.
Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities.
Support the execution and documentation of Design Validation & Verification and Usability activities.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).
Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
Lead and support cross-functional root-cause analysis investigation and resolution activities
Evaluate and support design test and inspection method development, and lead method validation activities
Support regulatory submissions to notified bodies.
Understanding of technologies incorporated into design.
Education/Experience:
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or Electrical Engineering.
2+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
Strong communication skills (verbal & written)
Ability to work in a highly matrixed and geographically diverse business environment
Demonstrated use of Quality tools/methodologies
