Quality Engineer

Quality Engineer IIIMake sure to read the full description below, and please apply immediately if you are confident you meet all the requirements.Job Summary: Talent Software Services is in search of a Quality Engineer for a contract to hire position in Maple Grove, MN. Position Summary: 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.Primary Responsibilities/Accountabilities: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 activitiesEvaluate and support design test and inspection method development, and lead method validation activitiesSupport regulatory submissions to notified bodies.Understanding of technologies incorporated into design.Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.Qualifications: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 experienceProblem solver, capable of facilitating the problem-solving processAdaptable and effective collaborator in a team environment and in self-directed workStrong communication skills (verbal & written)Ability to work in a highly matrixed and geographically diverse business environmentDemonstrated use of Quality tools/methodologiesPreferred:Previous Software or Capital equipment Design Assurance experience is a plusMedical device or other regulated industry experienceStrong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971), and software standards (IEC 62304 or IEC 82304)Experience with 60601, software and cybersecurityExperience working in an Agile environmentIf this job is a match for your background, we would be honored to receive your application!Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities including contract, contract to hire and permanent placement. Let's talk!

Created: 2025-02-28