QA/RA Manager
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| Company: | AVS View Company Profile | See all Jobs at this Company | |
|---|---|---|
| Job Location: | 5743 Thornwood Drive, Goleta, California 93117 | |
| Pay: | $2,692.00 to $4,615.00 per Every Other Week | |
| Date Posted: | July 19, 2010 | |
| Job ID: | 7151 | |
| Required Education: | Bachelor's Degree | |
| Required Experience: | 5+ to 7 Years |
Job Description
Seeking experienced QA management professional to actively participate within our senior management team and with all levels of our staff.
Must possess a desire to work in an innovative and collaborative environment within a fast-paced manufacturing facility.
Responsibilities include:
Manage QA department, which includes all QA Inspection, Document Control, Complaint Evaluation, Environmental Monitoring , Equipment Calibration, Shelf-life studies and maintenance of the Device History Records.
Establish and maintain the Quality System, ensuring ongoing compliance with FDA and European requirements for medical device design, manufacture and distribution.
Act as Management Representative, as defined in 21 CFR Part 820.20 (3).
Manage all activities of the Quality Assurance and Regulatory Affairs departments.
Development of any US or EU regulatory filings.
Liaison with parent company Regulatory and R&D groups, and coordination of activities related to regulatory filings in Japan.
Develop and submit all required regulatory filings, including IDEs, PMAs, 510(k)s, and communicate with FDA to ensure approval of all products.
Obtain and maintain ISO registration and CE marking for all products that will be marketed in Europe.
Identify preclinical testing requirements and ensure performance of all required tests.
Identify the required information for regulatory filings in Japan, and ensure performance of all required tests.
Submission of all adverse event information as required by the Medical Device Reporting regulation and the vigilance system.
Ensure personnel are trained in the requirements of the Quality System Regulation and ISO 9000 standards.
Provide leadership in Quality for the production and R&D departments * provide guidance to both departments on the requirements.
Organizing and conducting regular meetings w/ QA & Production
Provide expertise on the requirements of the ISO 10993 and 11979 series standards.
Must have management experience in QA/RA within a FDA regulated industry with strength in day-to-day 'hands on' attention to QA and Production staff
Must have technical experience and ability to grasp technical concepts
Must possess a college education and equivalent job experience
Excellent pay & full benefits include: Medical, Dental, Vision, FSA, EAP, 401k w/match of up to 5%, STD, LTD & Life.
Please submit resume to: AVS / HR Dept. 5743 Thornwood Dr., Goleta, CA 93117. Fax 805-683-1836. HR@AVSIOL.com
Job Requirements
Must have management experience in QA/RA within a FDA regulated industry with strength in day-to-day 'hands on' attention to QA and Production staff
Must have technical experience and ability to grasp technical concepts
Must possess a college education and equivalent job experience