We are looking to hire a Quality Engineer immediately!
Duties are as follow:
Provide engineering support in the development and maintenance of company's quality systems. Coordinate the reporting, analysis, and resolution of non-conformance incidences. Participate in Material Review Board meetings. Develop quality assurance specifications, test methods, sampling plans and related written procedures. Perform data analysis of production and inspection outcomes, using standard statistical methods. Identify and implement improvements on inspection equipment, methods and sample sizes. Coordinate the identification, assignment, monitoring, and completion of product and process improvement projects. Develop and conduct training programs regarding product quality and the Company's quality systems. Qualify and implement Document Changes Notices involving product or process changes. Provide quality assurance appraisal and approval or disapproval of suppliers. Conduct quality audits and develop subsequent preventive action programs. Coordinate activities of technicians and temporary workers as needed. Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products. Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Document Control, Clinical, and Research and Development functions. Provide support in the rapid resolution of product complaints and/or safety issues. Assist Regulatory Affairs Department in preparation of regulatory submissions and interface with the FDA or other regulatory agencies in case of on-site audits. Assist in document, monitoring and completing CAPAs. Work with the Manufacturing, Clinical Affairs, Sales and Marketing, and Research and Development functions to coordinate pilot production of new products.
BS in life sciences, engineering, or equivalent preferred. Minimum five to eight years related experience in the medical device industry. Knowledge of ISO 13485 Quality Systems Standard, 21 CFR 820 and ISO 14971 Application of Risk Management to Medical Devices preferred. ASQC membership. Lead Auditor Training. Use of Statistical Software.
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.