Job Description:
-Initiate, route, track and manage all Quality system procedures, processes and records.
-Distribute and maintain new or amended quality system documents and their associated logs.
-Control and file all active and obsolete documents that support the quality system. This includes such items as quality policies, operational procedures, work instructions, device history files and all device history records.
-Scan or transfer approved documents in a controlled database.
-Create, print and update product labeling.
-Assist with all document and all quality system and management review meetings.
-Provide other support as needed to the regulatory and quality assurance group, such as packaging and labeling of product.
Education and experience requirements:
-High school diploma or equivelent.
-Minimum 2 years of experience in the medical device field or related experience.
-Candidate must process the ability to multi task, have strong organizational and filing skills, be extremely detail oriented, meet stringent time deadlines and demonstrate strong written, and analytical skills.
-Must be a self starter that can work in a team environment, but also comfortable working independently.
-Must be proficient in Microsoft Word, Excel and Powerpoint. Knowledge of Microsoft Access is a plus.
-Familiar with FDA quality regualtions and ISO standards.
I'm putting this up here in hopes that I can find a good, friendly Desert person for this job. My company is a start up Medical Device company with less than 20 employees. We have a Gym with 24 hour access to the employees and if everything goes right, there are two bonus payouts per year. www.seaspine.com
PM me if you'd like to send a resume.
Oh yeah... job is in Vista.