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Company Contact Info
- Raleigh, NC
- Tucker Smith
- Phone: 9193798283
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Quality Engineer
Aerotek • Raleigh, NC
Posted 6 days ago
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Job Description
* Ensure that the planned project activities are compliant with standard operating procedures and ISO (i.e. 13485) quality systems, the FDA Quality System Regulation (QSR) regulations.
* Understand Design History File (DHF) content requirements and be capable of performing all aspects of DHF maintenance.
* Lead product Risk Analysis meetings and document the results as specified in ISO 14971. Follow up as required throughout the project to ensure adherence to risk management plan. Risk activities also include coordination of Design Failure Modes and Effect Analysis reports, Fault Tree Analysis, and other risk reports.
* Coordinate all Design Verification Test activities, including generation of the verification Plan, Procedures and Report documents.
* Review design related project documents and drawings to ensure internal and external requirements are met.
Must Haves:
- A Bachelor's degree in a scientific or engineering discipline
- Experience with quality standards - I.E. 60601, 13845, 14971, 62304 (Software QE). Need to be able to author project plans/requirement docs.
- Medical Device experience
- New Product Development Quality experience (Risk Management, Design History Files, Design Document for verification process)
- Sr QE (At least 10 years of experience)
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.
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.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.
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 become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With more than 230 non-franchised offices, Aerotek’s 6,000 internal employees serve more than 300,000 contract employees and 17,000 clients every year. To learn more, visit Aerotek.com.
Contact Info
- Raleigh, NC
- Tucker Smith
- Phone: 9193798283
