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