200+ applicantsPosted by Agency
TALENT Software Services ยท 3 days ago
Quality Engineer
Maple Grove, MN
Full-time
Hybrid
Mid Level
2+ years exp
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Responsibilities
Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
Act as an effective team member in supporting quality disciplines, decisions, and practices
Work within a cross-functional team to identify and implement effective controls and support commercial design changes, specifically with regard to quality and risk management
Support the verification, validation, and usability testing to meet or exceed internal and external requirements
Perform regulatory standard assessments and support regulatory submissions to notified bodies
Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
Update and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)
Qualification
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Required
Bachelor's degree in biomedical, Mechanical, or Electrical Engineering, or related field of study
2+ years of experience in design assurance, new product development, or related experience in a highly regulated industry
Demonstrated use of Quality tools/methodologies
Strong verbal and written communication skills
Self-motivated with a passion for solving problems and a bias for action
Effectively work and collaborate in a hybrid (onsite plus remote) environment
Preferred
Prior medical device industry experience, particularly with medical electrical equipment
Working knowledge of US and International regulations including ISO 13485, ISO 14971, IEC 60601-1, EN 62366, and Quality System Regulations
Experience in managing multiple projects across multiple organizational disciplines
Company
TALENT Software Services
Talent Software Services is an IT staffing services company of healthcare and government sectors.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Dave Iacarella
Founder & CEO
Prashanth Upadrashta
Vice President -Global Operations & Delivery
Recent News
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