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Quality Engineer
3 months ago
Quality Engineer
Make your application after reading the following skill and qualification requirements for this position.
Job Summary: Talent Software Services is in search of a Quality Engineer for a contract position in Maple Grove, MN(Hybrid). The opportunity will be one year with a strong chance for a long-term extension.
Position Summary: The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. This role will work within high-performance, cross-functional teams to ensure safety, quality, and compliance of commercialized products while continuously improving their value through end-of-life. Design Assurance drives the ISO 14971 risk management process and the 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. This role will be responsible for ensuring quality and compliance through product development and commercialization for medical electrical equipment/systems (MEE) within the Interventional Cardiology (IC) division. This person will be helping with sustainment of CAPA work and solutions - on development side.
Primary Responsibilities/Accountabilities: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)
Qualifications:Bachelor's degree in biomedical, Mechanical, or Electrical Engineering, or related field of study
Plus 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
If 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
