Quality Assurance Coordinator – Medical Devices – FILLED
The Wellington Group has been engaged to find an experienced Quality Assurance Coordinator – Medical Devices QA/QC experience. This is a great opportunity to work for one of the industry’s leading medical device companies with a focus on current and future technologies.
The Quality Assurance Coordinator – Medical Devices is responsible ensuring compliance of both FDA and internal standards with third-party or outside laboratories.
Quality Assurance Coordinator – Medical Devices responsibilities include:
- Assigns, reviews, and evaluates the work of third party labs
- Focused on the compliance and systems side of the QA/QC Department, definitions and terminology
- Monitors CAPA or OOS issues and unusual occurrences, report follow-up procedures, and report monthly and year-to-date comparisons
- Responsible for CAPA training and tracking
- Assist the director with SOP revisions and maintenance
- Reviews quality assurance standards, studies existing policies and procedures, and interviews personnel, consultants and vendors to evaluate effectiveness of quality assurance program
- Interface with outside labs, review inspections, samples and batches for release
The qualified Quality Assurance Coordinator – Medical Devices candidate will have:
- Associate’s Degree in Science, Chemistry or related field required, Bachelor’s degree preferred
- Five (5) to ten (10) years experience in quality assurance and/or quality control
- Hands on experience with FDA and ISO audits
- Experience with medical devices is a plus
Industry: Medical Device, Biotechnology, Combination Products, QA, QA Coordinator