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Quality Engineer

Company: Aerotek
Location: Raleigh
Posted on: January 15, 2021

Job Description:

Description:Quality assurance support in the design and development support of medical device products, facilitating the application of design/change controls, risk management, quality plan, and implementation of design and development plan.Act as SME for key subsystems such as Design Control, Risk Management, Design Verification, Design Validation, Process Validation, etc.Skills:quality engineering, medical device, document review, document control, iso 13485, Design control, Risk management, Design verification, Design validation, Process validation, quality management system software, Product development process, Product development engineeringAdditional Skills & Qualifications:BS in Engineering (or equivalent) and a minimum of 4 years' experience in the regulated medical device industry as a Quality Assurance Engineer supporting new product development is preferred.Excellent Quality System knowledge required. Practical experience with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Documentation Practices, and other applicable standards.Working knowledge of principles, concepts, and practices for design and development activities, Risk Management, FDA 510K submissions, and ISO Regulations.MasterControl experience strongly preferred. About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Raleigh , Quality Engineer, Engineering , Raleigh, North Carolina

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