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Quality Intern - Post Market

Company: Staar Surgical
Location: Monrovia
Posted on: January 16, 2022

Job Description:

This is a 6-month temporary assignment.
MAIN JOB RESPONSIBILITIES / COMPETENCIES1. Act as consolidation point for receiving, processing, investigating and reporting product complaints.2. Perform prompt identification and evaluation of device product complaints for potential reportable adverse events.3. Ensure Medical Device Reports and Vigilance reports are submitted in compliance with U.S. FDA Regulations, EU and Canadian Medical Device Directives and Regulations, Australia, Japan and other appropriate regulations and guidelines.4. Coordinate complaint investigations according to complaint handling procedures, which includes but is not limited to:a. interface with physicians and/or health care professionals regarding information relevant to the product complaint.b. interface and coordinate with Regulatory, Quality, Clinical Affairs and Medical Reviewer to conduct investigations, risk assessments and determine reporting requirements, both in the U.S. and internationally.5. Ensure accuracy, integrity, completeness and consistent content of all product complaint reports, investigations, MDR and Vigilance reports, in the complaint files and electronic complaint database.6. Utilize the Corrective Action/Preventive Action process, when appropriate, as a result of complaint investigation, managing an MDR or complaint trend.7. Ensure complaint files are stored according to procedure.8. Participate in external (FDA, ISO) and internal audits as required9. Provide support, as required for other aspects of the post-market surveillance system. (i.e., data analysis of complaint reports, files and adverse event reporting logs.)10. Good communication skills, written and verbal.
EDUCATION & TRAINING High School graduate or equivalent required.Associates Degree or higher desired.
EXPERIENCE Minimum 1-year ophthalmic experience, or equivalent combination of education and experience preferred. Minimum 3 years experience in FDA regulated industry preferred; experience handling complaints and medical device reporting is highly desirable. Demonstrated understanding of, and ability to interpret, regulations and guidelines governing medical device manufacturing, includingbut not limited to, CFRs, ISO 13485, MDD, CMDR preferred.
SKILLS Proficiency in MS Word and Excel. Ability to work well within a team and interdepartmentally. Special competencies: timely and quality decision making; well developed organizational ability, time management reasoning and problem-solving skills.by Jobble

Keywords: Staar Surgical, Los Angeles , Quality Intern - Post Market, Other , Monrovia, California

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