Atossa Genetics is a women’s healthcare company specializing in the development of proprietary medical devices and laboratory services to stratify, assess, profile, and monitor the breast health in patients.
We accept enthusiastic, high quality undergraduate or graduate students interested in learning the industry as interns. Stipend may be awarded depending on the skills and experiences. Please send your resume and contact information for two references to firstname.lastname@example.org.
QUALITY/REGULATORY AFFAIRS TECHNICIAN
Under the direction of the Manager, Quality Assurance/Regulatory Affairs, this position will provide Quality System and Regulatory Affairs support and guidance to the Operations, Engineering, QA/RA, Clinical and Sales teams.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Reviews and approves work for inclusion in complaints, Medical Device Reports (MDRs), adverse events and audits and assists in the management of actions and tasks which support these activities.
- Assists and participates in corrective and preventive actions (CAPA)-related activities.
- Assists and handles document control activities.
- Communicates issues or developments identified during quality assurance activities and provides recommended improvements to responsible functional areas.
- Assists in the ECO/DCO process, Label Reviews and provides guidance to product development teams throughout the product development process (PDP) to ensure compliance to the required PDP deliverables, resulting in the development of safe and effective medical devices.
- Periodically reviews the suitability and effectiveness of the quality system with management. Analyzes data from various sources (including, but not limited to: Non-Conformances, Complaints, etc.) to drive decision-making and effective corrective/preventive actions.
- Assists in maintaining documentation associated from nonconformance’s, complaints, audits etc. to ensure documents for the QMS are properly maintained
- Recommends, leads, and/or supports projects for improvements to the Quality System.
- Assists functional groups during FDA Inspections, ISO audits etc. to provide objective evidence required during those activities
- Ability to communicate and/or liaison effectively with various regulatory bodies (FDA, ISO, NRTL etc.)
Education, Experience and/or Skills Required
- AAS in engineering/business related area or equivalent experience in a medical device environment.
- 2-5 or more years of relevant medical device industry experience with Class I, II, and III devices
- Comprehensive knowledge of Quality concepts, regulatory compliance requirements and tools including ISO 13485:2003, FDA QSRs, Medical Device Directives, Canadian Medical Device Regulations, etc.
- Completely proficient in product & process development concepts, including change control and risk management.
- Applies organizational and technical knowledge to move teams through issues.
- Problem solving abilities applying statistical techniques to address issues and investigations.
- Excellent written and verbal communication skills including ability to communicate technical information. Must be fluent in English
- ASQ Certification or similar preferred.
- Knowledgeable of MS Office to include PowerPoint & Excel – knowledgeable of creating charts, graphs and statistical analyses.
To apply for this position please send your resume to email@example.com.