Job Summary/ Overview:
The QA/QC intern, who will report to the Quality control manager, should be interested in polices and activities in the areas of medical device, quality, compliance, and submission. The intern is responsible for performing inspections, checks, tests, and sampling procedures of incoming materials, parts and components used in the manufacture of medical devices, partially assembled or finished medical devices.
Manages all aspects of the Quality System and processes to ensure compliance with Quality System Regulations and International Standards supporting regulatory and certification requirements
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Knowledge on Corrective and Preventive Action (CAPA) processes in order to maintain CAPA records.
To review new or revised documents for compliance with the Epinex Quality System and any applicable regulations.
Responsible for periodic review of department internal control procedures.
Perform sampling, inspection, and testing.
Accurately document the results of the inspections and testing.
Maintain all controlled document files and test records in a timely and accurate manner.
Perform office duties when necessary.
Education and Skill Requirements:
Bachelor’s Degree in Biology, Chemistry, engineering or related discipline.
Basic FDA knowledge preferred.
Statistical knowledge preferred.
General proficiency of Microsoft Excel and Microsoft Word.
Ability to work independently and remain self-motivated with minimal direct supervision.
Strong organization skills and close attention to detail.
Good interpersonal skills.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
It is the policy of Epinex Diagnostics to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, Epinex will provide reasonable accommodations for qualified individuals with disabilities.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills, required of employees assigned to this position.
To apply, please email your cover letter, unofficial transcript, and resume to Marco Robles (Marco@epinex.com).