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Quality Assurance and Regulatory Affairs Specialist
| Details |
Country: USA
Location: CA San Mateo
Total applied: 6
Relevant Work Experience: 2+ to 5 Years
Career Level: Experienced (Non-Manager)
Education Level: Bachelor's Degree
Job Type: Employee
Job Status: Full Time
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Quality Assurance and Regulatory Affairs Specialist
Quality Assurance and Regulatory Affairs Specialist
About the company:
TeraRecon, Inc. is an imaging technology company that develops, markets and supports systems and subsystems for professional imaging applications, with special emphasis on medical imaging. Its mission is to develop and deploy innovative products that deliver high performance and superior image quality based on unique technologies for professional imaging applications in medical, geophysical, industrial and scientific markets. To learn more about the company, visit us on-line at www.terarecon.com
About the position:
The Quality Assurance and Regulatory Affairs Specialist will assist in regulatory compliance and maintenance of the TeraRecon quality system. Looking for an individual with attention to detail, dedication, and a desire to learn. This individual will conduct internal audits, play a major role in CAPA, train new employees on the QMS, research and participate in US and international regulatory requirement compliance, among other responsibilities.
Qualifications and Experience:
-BA degree
-Strong research skills
-0-3 yrs quality or regulatory experience
-Knowledge and understanding of ISO 13485 is a plus
-Understanding of the FDA, 93/42/EEC, ISO 14971 a plus
-Understanding the software development cycle is a plus
-Medical device experience is a plus
RELOCATION IS NOT PROVIDED. WILL NOT PROVIDE VISA SPONSORSHIP.
Salary: Depending on experience and qualifications. Compensation package will include medical, dental, vision, life insurance, LTD, STD, Sect 125, 401k and stock option benefits. TeraRecon is an equal opportunity employer.
Qualified applicants should email a cover letter and resume to: qualityspecialist@terarecon.com
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Biotechnology and Pharmaceutical 
